Base plate and sensor assembly of a medical system having a leakage sensor

ABSTRACT

The disclosed is an ostomy system configured to detect a leakage of output between a base plate and/or a sensor assembly part of the ostomy system and a surface of a subject and a method of detecting the leakage of output. The ostomy system including the base plate and/or the sensor assembly part and a monitor device, the base plate and/or the sensor assembly part comprising (i) a first adhesive layer having a distal surface, a proximal surface, and a first plurality of openings, and (ii) an electrode assembly comprising a plurality of electrodes and a masking element between the plurality of electrodes and the first adhesive layer, the masking element having a second plurality of openings aligned with the first plurality of openings of the first adhesive layer, each of the aligned first and second plurality of openings exposes a portion of one of the plurality of electrodes to define one of a plurality of sensor points, the monitor device electrically coupled to the plurality of electrodes of the base plate and/or the sensor assembly part.

The present disclosure relates to an ostomy system, devices thereof andmethod for monitoring an ostomy appliance. The ostomy appliance systemcomprises an ostomy appliance and an ostomy monitor device. Inparticular, the present disclosure relates to leakage classificationand/or detection and monitoring of the operation of an ostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate and/or a sensorassembly part,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8 ,

FIG. 10 is a distal view of a part of the base plate and/or a sensorassembly part including a monitor interface,

FIG. 11 is a proximal view of an exemplary base plate showing theleakage of output,

FIG. 12 is a proximal view of an exemplary base plate including a sensorpoint,

FIG. 13 is a cross-sectional view of an exemplary base plate of theostomy system,

FIG. 14 illustrates an exemplary resistance measurement,

FIG. 15 illustrates sensing zones arranged radially,

FIG. 16 illustrates sensing zones arranged concentrically,

FIG. 17 depicts an illustrative method for detecting an indication ofleakage of output.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of moisture propagation in the adhesivematerial provided for attaching the base plate to the skin surface of auser.

Depending on the nature of the pattern of moisture propagation in theadhesive, the ostomy system and devices thereof enable providinginformation to the user about the type of failure, and in turn enableproviding an indication to the user of the severity and thus theremaining time frame for replacing the ostomy appliance withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The ostomy appliance includes a base plate, such as a monolithic,one-piece base plate, e.g. integrated with a sensor assembly part, or abase plate and a separate sensor assembly part, such as a sensorassembly part to be subsequently applied to a base plate. For example,to allow an arbitrary base plate, such as a conventional base plate, toachieve the features as described herein. Features as described withrespect to the base plate herein may be provided by a sensor assemblypart to be applied to a base plate, e.g. by the user. A sensor assemblypart may be adapted to adhere to an ostomy plate.

A disclosed method of attaching a base plate to a user's stoma and/orskin surrounding the stoma, such as the peristomal skin area, maycomprise attaching a sensor assembly part to a base plate and attachingthe base plate, e.g. together with the attached sensor assembly part, tothe user's stoma and/or skin surrounding the stoma, such as theperistomal skin area. Alternatively, the method of attaching the baseplate to the user's stoma and/or skin surrounding the stoma may compriseattaching the sensor assembly part to the user's stoma and/or skinsurrounding the stoma and attaching the base plate to the user's stomaand/or skin surrounding the stoma above the attached sensor assemblypart.

The base plate and/or the sensor assembly part may comprise a firstadhesive layer, also denoted center adhesive layer. During use, thefirst adhesive layer adheres to the user's skin (peristomal area) and/orto additional seals, such as sealing paste, sealing tape and/or sealingring. Thus, the first adhesive layer may be configured for attachment ofthe base plate and/or the sensor assembly part to the skin surface of auser. The first adhesive layer may have a stomal opening, such as afirst adhesive stomal opening, with a center point.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocoloids. The first composition may comprise one or more watersoluble or water swellable hydrocolloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The firstcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The first composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

The first adhesive layer may have a plurality of sensor point openingswhich may be denoted as a first plurality of openings. A sensor pointopening of the first adhesive layer is optionally configured to overlapa part of an electrode, such as a leakage electrode, e.g. to form asensor point.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap parts of an electrode, such as a firstleakage electrode, and the primary second sensor point openingsconfigured to overlap parts of another electrode, such as a secondleakage electrode, different from the electrode at least partlyoverlapped by the primary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap parts of an electrode, such as athird leakage electrode, and the secondary second sensor point openingsconfigured to overlap parts of another electrode, such as the secondleakage electrode, different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap parts of an electrode, such as thethird leakage electrode, and the tertiary second sensor point openingsconfigured to overlap parts of another electrode, such as the firstleakage electrode, different from the electrode at least partlyoverlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate and/or the sensor assembly part may comprise a secondlayer. The second layer may be an adhesive layer, also denoted rimadhesive layer. The second layer may have a second radial extension thatis larger than a first radial extension of the first adhesive layer atleast in a first angular range of the base plate and/or the sensorassembly part. Accordingly, a part of a proximal surface of the secondlayer may be configured for attachment to the skin surface of a user.The part of a proximal surface of the second layer configured forattachment to the skin surface of a user is also denoted the skinattachment surface of the second adhesive layer. The second layer mayhave a stomal opening, such as a second layer stomal opening and/or asecond adhesive stomal opening, with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocoloids. The second composition may comprise one or more watersoluble or water swellable hydrocolloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIS). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocoloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively or additionally, thesecond adhesive layer may be thinner than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lessmouldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate and/or the sensor assembly part may comprise one or moreelectrodes, such as a plurality of electrodes, such as two, three, four,five, six, seven or more electrodes. The sensor assembly part may beapplied to the base plate, such as to provide the base plate with theone or more electrodes.

The electrodes, e.g. some or all the electrodes, may be arranged betweenthe first adhesive layer and the second adhesive layer. The electrodesmay be arranged in an electrode assembly, e.g. an electrode layer. Anelectrode comprises a connection part for connecting the electrodes toother components and/or interface terminals/terminal elements. Anelectrode may comprise one or more conductor parts and/or one or moresensing parts. A conductor part may be considered part of an electrodeconnecting two or more sensing parts, and/or connecting a sensing partwith a connection part of the respective electrode. A sensing part maybe considered a part of the electrode being suitable for sensing, e.g.liquid, such as liquid content, and/or output, such as output resultingfrom a leakage, or an imminent leakage. The sensing part may be suitablefor sensing e.g. by its shape, said shape potentially being circular,oval, or rectangular. Thus, the conductor part may conduct a signalarising from the sensing part. An electrode may comprise alternatingconductor parts and sensing parts. The electrode assembly may bearranged between the first adhesive layer and the second adhesive layer.The base plate and/or the sensor assembly part, e.g. the electrodeassembly, may comprise a first electrode, a second electrode andoptionally a third electrode. The base plate and/or the sensor assemblypart, e.g. the electrode assembly, may comprise a fourth electrodeand/or a fifth electrode. The base plate and/or the sensor assemblypart, e.g. the electrode assembly, optionally comprises a sixthelectrode. The base plate and/or the sensor assembly part, e.g. theelectrode assembly, may comprise a ground electrode. One of theplurality of electrodes, such as the ground electrode, may form a firstleakage electrode. One of the plurality of electrodes, such as thefourth electrode, may form a second leakage electrode. One of theplurality of electrodes, such as the fifth electrode, may form a thirdleakage electrode. The ground electrode may comprise a first electrodepart. The first electrode part of the ground electrode may form a groundfor the first electrode. The ground electrode may comprise a secondelectrode part. The second electrode part of the ground electrode mayform a ground for the second electrode. The ground electrode maycomprise a third electrode part. The third electrode part of the groundelectrode may form a ground for the third electrode. The groundelectrode may comprise a fourth electrode part. The fourth electrodepart of the ground electrode may form a ground for the fourth electrodeand/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair. The fourth electrode and the fifthelectrode may form a sixth sensor or sixth electrode pair.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The electrodes may be prepared by screen-printing, inkjet-printing,direct-ink-writing, pen-plotting, 3D-printing,fused-deposition-modelling, contact-transfer printing, spray painting,chemical vapour depositing, physical vapour depositing,atomic-layer-depositing, wire-bending, and/or any other methods known toa person skilled in the art. The plurality of electrodes may furtherrequire heat-curing, UV-curing, and/or oxygen-activating.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Theelectrode assembly, such as the support layer of the electrode assembly,may have a stomal opening, such as an electrode assembly stomal openingand/or a support layer stomal opening, with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates and/or sensor assembly parts, the support layer ismade of thermoplastic polyurethane (TPU). The support layer material maybe made of or comprise one or more of polyester, a thermoplasticelastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA),polyurea, and silicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate, and/or the sensor assembly part, such as the electrodeassembly may comprise a masking element configured to insulate at leastparts of the electrodes from the first adhesive layer of the base plateand/or the sensor assembly part. The masking element may comprise one ormore, such as a plurality of, sensor point openings which may be denotedas a second plurality of openings. The sensor point openings maycomprise primary sensor point openings and/or secondary sensor pointopenings. The sensor point openings may comprise tertiary sensor pointopening(s). The sensor point openings may comprise quaternary sensorpoint opening(s). A sensor point opening of the masking element overlapsat least one electrode of the electrode assembly when seen in the axialdirection, e.g. to form a sensor point. For example, a primary sensorpoint opening may overlap a part of the ground electrode (e.g. the firstleakage electrode) and/or a part of the fourth electrode (e.g. thesecond leakage electrode). A secondary sensor point opening may overlapa part of the fourth electrode (e.g. the second leakage electrode)and/or a part of the fifth electrode (e.g. the third leakage electrode).A tertiary sensor point opening may overlap a part of the fifthelectrode (e.g. the third leakage electrode) and/or a part of the groundelectrode (e.g. the first leakage electrode).

The masking element may comprise one or more, such as a plurality of,terminal openings. The masking element may comprise polymeric (e.g.polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica)materials. In one or more exemplary base plates and/or sensor assemblyparts, the masking element is made of or comprises thermoplasticpolyurethane (TPU). In one or more exemplary base plates and/or sensorassembly parts, the masking element is made of or comprises polyester.The masking element material may be made of or comprise one or more ofpolyester, a thermoplastic elastomer (TPE), polyimide, polyimide,Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly part may comprise a firstintermediate element. The first intermediate element may be arrangedbetween the electrodes/electrode layer and the first adhesive layerand/or between the second layer and the first adhesive layer. The firstintermediate layer may be made of an insulating material.

The base plate and/or the sensor assembly part may comprise a releaseliner. The release liner is a protective layer that protects adhesivelayer(s) during transport and storage and is peeled off by the userprior to applying the base plate on the skin. The release liner may havea stomal opening, such as a release liner stomal opening, with a centerpoint.

The base plate and/or the sensor assembly part may comprise a top layer.The top layer is a protective layer protecting the adhesive layer(s)from external strains and stress when the user wears the ostomyappliance. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the top layer. The toplayer may have a stomal opening, such as a top layer stomal opening,with a center point. The top layer may have a thickness in the rangefrom 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, suchas 0.04 mm.

The base plate and/or the sensor assembly part may comprise a monitorinterface. The monitor interface may be configured for electricallyand/or mechanically connecting the ostomy appliance (base plate and/orsensor assembly part) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (base plateand/or sensor assembly part) to the monitor device. Thus, the monitorinterface of the base plate and/or the sensor assembly part may beconfigured to electrically and/or mechanically couple the ostomyappliance and the monitor device.

The monitor interface of the base plate and/or of the sensor assemblypart may comprise, e.g. as part of a first connector of the monitorinterface, a coupling part for forming a mechanical connection, such asa releasable coupling between the monitor device and the base plateand/or the sensor assembly part. The coupling part may be configured toengage with a coupling part of the monitor device for releasablycoupling the monitor device to the base plate and/or the sensor assemblypart.

The monitor interface of the base plate and/or the sensor assembly partmay comprise, e.g. as part of a first connector of the monitorinterface, a plurality of terminals, such as two, three, four, five,six, seven or more terminals, for forming electrical connections withrespective terminals of the monitor device. The monitor interface maycomprise a ground terminal element forming a ground terminal. Themonitor interface may comprise a first terminal element forming a firstterminal, a second terminal element forming a second terminal andoptionally a third terminal element forming a third terminal. Themonitor interface may comprise a fourth terminal element forming afourth terminal and/or a fifth terminal element forming a fifthterminal. The monitor interface optionally comprises a sixth terminalelement forming a sixth terminal. The terminal elements of the monitorinterface may contact respective electrodes of the base plate and/or thesensor assembly part, such as the electrode assembly. The firstintermediate element may be arranged between the terminal elements andthe first adhesive layer. The first intermediate element may cover oroverlap terminal element(s) of the base plate and/or the sensor assemblypart when seen in the axial direction. Thus, the first adhesive layermay be protected or experience more evenly distributed mechanical stressfrom the terminal elements of the base plate and/or of the sensorassembly part, in turn reducing the risk of terminal elementspenetrating or otherwise damaging the first adhesive layer. The firstintermediate element may protect or mechanically and/or electricallyshield the first adhesive layer from the terminal elements of the baseplate and/or the sensor assembly part.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate and/or the sensor assembly part may have astoma-receiving opening with a stoma center point, such as a stomalopening with a center point, alternatively such opening may be denoted acentral opening. The stomal opening of the base plate and/or the sensorassembly part may be formed collectively of stomal opening(s) of thelayers of the base plate and/or the sensor assembly part, such as of thetop layer, the first adhesive layer, the second layer and/or the sensorassembly part. The stomal opening(s) of the layers of the base plateand/or the sensor assembly part, such as of the top layer, the firstadhesive layer, the second layer and/or the sensor assembly part may bealigned to form the stomal opening of the base plate and/or the sensorassembly part. The stomal opening may be a through-going passage of thebase plate and/or the sensor assembly part. The stomal opening may bearranged substantially in the center of the base plate and/or the sensorassembly part. The stomal opening(s) of the layers of the base plateand/or the sensor assembly part may be arranged substantially in thecenter of the respective layer. The stomal opening may be configured toreceive a stoma of the user and/or the stomal opening may be configuredto allow output from the stoma to pass through the stomal opening aninto an ostomy pouch attached to the base plate. For example, the stomalopening may be configured to allow passage of output from a proximalside of the base plate and/or sensor assembly part to a distal side ofthe base plate and/or sensor assembly part. The size and/or shape of thestomal opening may typically be adjusted by the user or nurse beforeapplication of the ostomy appliance to accommodate the user's stoma. Inone or more exemplary base plates, the user forms the stomal openingduring preparation of the base plate for application.

The monitor device comprises a processor and one or more interfaces,such as a first interface and/or a second interface. The monitor devicemay comprise a memory for storing ostomy data.

In one or more exemplary monitor devices, the processor is configured toapply a processing scheme, the first interface is connected to theprocessor and the memory, and the first interface is configured forcollecting ostomy data from the base plate and/or the sensor assemblypart coupled to the first interface. The ostomy data may comprise one ormore, such as all, of first ostomy data from a first electrode pair ofthe base plate and/or the sensor assembly part, second ostomy data froma second electrode pair of the base plate and/or the sensor assemblypart, and third ostomy data from a third electrode pair of the baseplate and/or the sensor assembly part. A second interface is connectedto the processor. To apply a processing scheme may comprise one or moreof obtain first parameter data based on the first ostomy data; obtainsecond parameter data based on the second ostomy data; and obtain thirdparameter data based on the third ostomy data. To apply a processingscheme may comprise determine an operating state of the base plateand/or the sensor assembly part of the ostomy appliance based on one ormore, such as all, of the first parameter data, the second parameterdata and the third parameter data. The operating state may be indicativeof a degree of radial erosion of the base plate and/or the sensorassembly part, such as of the first adhesive layer, and/or an acuteleakage risk for the ostomy appliance. The monitor device is configuredto, in accordance with a determination that the operating state is afirst operating state, transmit a first monitor signal comprisingmonitor data indicative of the first operating state of the base plateand/or the sensor assembly part via the second interface; and/or inaccordance with a determination that the operating state is a secondoperating state, transmit a second monitor signal comprising monitordata indicative of the second operating state of the base plate and/orthe sensor assembly part via the second interface.

In one or more exemplary monitor devices, the first operating state ofthe base plate and/or the sensor assembly part corresponds to asituation wherein the first adhesive layer of the base plate and/or thesensor assembly part has experienced a first degree of radial erosion,e.g. the first adhesive layer is eroded to a first radial distance ofthe first electrode pair but not to a second radial distance of thesecond electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate and/or the sensor assembly part corresponds to asituation wherein the first adhesive layer of the base plate and/or thesensor assembly part has experienced a second degree of radial erosion,e.g. the first adhesive layer is eroded to the second radial distance ofthe second electrode pair but not to a third radial distance of thethird electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data. In one ormore exemplary monitor devices, determination of an operating state maybe based on one or more fourth parameters, such as fourth primaryparameter and/or fourth secondary parameter of the fourth parameterdata.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on afirst criteria set based on the first parameter data and/or the secondparameter data, wherein the operating state is determined to be thefirst operating state if the first criteria set is satisfied. The firstcriteria set may comprise one or more first criteria based on one ormore of first parameter data, second parameter data and third parameterdata. The first criteria set may comprise a first primary criterionbased on the first parameter data. The first criteria set may comprise afirst secondary criterion based on the second parameter data. The firstcriteria set may comprise a first tertiary criterion based on the thirdparameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part may be based ona first threshold set comprising one or a plurality of first thresholdvalues. The first threshold set may comprise one or a plurality ofthreshold values, e.g. to be applied in the first criteria set. Thefirst threshold set may comprise a first primary threshold value. Thefirst threshold set may comprise a first secondary threshold value. Thefirst threshold set may comprise a first tertiary threshold value.

The first criteria set may be given by(P_1_1<TH_1_1),(P_2_1>TH_1_2), and(P_3_1>TH_1_3),wherein P_1_1 is a first primary parameter based on the first parameterdata, TH_1_1 is a first primary threshold value, P_2_1 is a secondprimary parameter based on the second parameter data, TH_1_2 is a firstsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data, and TH_1_3 is a first tertiary thresholdvalue, and wherein the first operating state is indicative of low degreeof radial erosion on the base plate and/or the sensor assembly part. Thefirst threshold values (TH_1_1, TH_1_2 and TH_1_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The first tertiary criterion(P_3_1<TH_1_3) may be omitted in the first criteria set.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate and/or the sensorassembly part.

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate and/or the sensor assembly part.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate and/or the sensor assembly part.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on asecond criteria set based on the second parameter data and/or the thirdparameter data, wherein the operating state is determined to be thesecond operating state if the second criteria set is satisfied. Thesecond criteria set may be based on the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on asecond threshold set comprising one or a plurality of second thresholdvalues. The second threshold set may comprise one or a plurality ofthreshold values, e.g. to be applied in the second criteria set. Thesecond threshold set may comprise a second primary threshold value. Thesecond threshold set may comprise a second secondary threshold value.The second threshold set may comprise a second tertiary threshold value.

The second criteria set may be given by(P_1_1<TH_2_1),(P_2_1<TH_2_2), and(P_3_1>TH_2_3)wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_2_1 is a second primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_2_2 is a secondsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_2_3 is a second tertiary threshold value, andwherein the second operating state is indicative of medium degree ofradial erosion on the base plate and/or the sensor assembly part. Thesecond threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The second primary criterion(P_1_1<TH_2_1) and/or the second tertiary criterion (P_3_1>TH_2_3) maybe omitted in the second criteria set.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on adefault criteria set based on the first parameter data, wherein theoperating state is determined to be the default operating state if thedefault criteria set is satisfied, and in accordance with adetermination that the operating state is the default operating state,transmit a default monitor signal comprising monitor data indicative ofthe default operating state of the ostomy appliance.

The default criteria set may be given by(P_1_1>TH_D_1),(P_2_1>TH_D_2), and(P_3_1>TH_D_3)wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_D_1 is a default primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_D_2 is a defaultsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_D_3 is a default tertiary threshold value, andwherein the default operating state is indicative of very low or nodegree of radial erosion on the base plate and/or the sensor assemblypart. The default threshold values (TH_D_1, TH_D_2 and TH_D_3) may bethe same or different, e.g. depending on the electrode configuration ofthe base plate and/or the sensor assembly part.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on athird criteria set based on the third parameter data, wherein theoperating state is determined to be the third operating state if thethird criteria set is satisfied, and in accordance with a determinationthat the operating state is the third operating state, transmit a thirdmonitor signal comprising monitor data indicative of the third operatingstate of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate and/or the sensor assembly part corresponds to asituation wherein the first adhesive layer of the base plate and/or thesensor assembly part has experienced a third degree of radial erosion,e.g. the first adhesive layer is eroded to the third radial distance ofthe third electrode pair.

The third criteria set may be given by(P_1_1<TH_3_1),(P_2_1<TH_3_2), and(P_3_1<TH_3_3)wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_3_1 is a third primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_3_2 is a thirdsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_3_3 is a third tertiary threshold value, andwherein the third operating state is indicative of high degree of radialerosion on the base plate and/or the sensor assembly part. The thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The third primary criterion(P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) maybe omitted in the third criteria set.

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair (e.g. first leakageelectrode and second leakage electrode) of the base plate and/or thesensor assembly part. To apply a processing scheme may comprise toobtain fourth parameter data based on the fourth ostomy data, anddetermine an operating state of the base plate and/or the sensorassembly part of the ostomy appliance based on the fourth parameterdata. The monitor device may be configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate and/or the sensor assembly part corresponds to asituation, wherein the fourth electrode pair detects fluid, such asoutput, between the distal surface of first adhesive layer and the skinof the user at a fourth radial distance and/or within a fourth anglespace, and thus there is a high risk of leakage from the ostomyappliance in the fourth operating state.

The fourth criteria set may be given by(P_4_1<TH_4_4)wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair and TH_4_4 is a fourth quaternary threshold value, andwherein the fourth operating state is indicative of high risk of leakagefrom the ostomy appliance.

In one or more exemplary monitor devices, the ostomy data comprisesfifth ostomy data from a fifth electrode pair (e.g. third leakageelectrode and second leakage electrode) of the base plate and/or thesensor assembly part. To apply a processing scheme may comprise toobtain fifth parameter data based on the fifth ostomy data, anddetermine an operating state of the base plate and/or the sensorassembly part of the ostomy appliance based on the fifth parameter data.The monitor device may be configured to, in accordance with adetermination that the operating state is a fifth operating state,transmit a fifth monitor signal comprising monitor data indicative ofthe fifth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fifth operating state ofthe base plate and/or the sensor assembly part corresponds to asituation, wherein the fifth electrode pair detects fluid, such asoutput, between the distal surface of first adhesive layer and the skinof the user at a fifth radial distance and/or within a fifth anglespace, and thus there is a high risk of leakage from the ostomyappliance in the fifth operating state.

The fifth criteria set may be given by(P_5_1<TH_5_5)wherein P_5_1 is a fifth primary parameter based on the fifth parameterdata and indicative of the resistance between the fifth electrode pairand TH_5_5 is a fifth quinary threshold value, and wherein the fifthoperating state is indicative of high risk of leakage from the ostomyappliance.

In one or more exemplary monitor devices, the ostomy data comprisessixth ostomy data from a sixth electrode pair (e.g. third leakageelectrode and first leakage electrode) of the base plate and/or thesensor assembly part. To apply a processing scheme may comprise toobtain sixth parameter data based on the sixth ostomy data, anddetermine an operating state of the base plate and/or the sensorassembly part of the ostomy appliance based on the sixth parameter data.The monitor device may be configured to, in accordance with adetermination that the operating state is a sixth operating state,transmit a sixth monitor signal comprising monitor data indicative ofthe sixth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the sixth operating state ofthe base plate and/or the sensor assembly part corresponds to asituation, wherein the sixth electrode pair detects fluid, such asoutput, between the distal surface of first adhesive layer and the skinof the user at a sixth radial distance and/or within a sixth anglespace, and thus there is a high risk of leakage from the ostomyappliance in the sixth operating state.

The sixth criteria set may be given by(P_6_1<TH_6_6)wherein P_6_1 is a sixth primary parameter based on the sixth parameterdata and indicative of the resistance between the sixth electrode pairand TH_6_6 is a sixth senary threshold value, and wherein the sixthoperating state is indicative of high risk of leakage from the ostomyappliance.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.Additionally or alternatively, the monitor device may be rigid orflexible.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and//or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate and/or the sensor assemblypart. The coupling part and the terminals of the first interface form(at least part of) a first connector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery. Additionally, oralternatively, the sensor terminal may change its function if thecharging voltage is sensed at relevant terminals.

The monitor device may comprise a sensor unit with one or more sensors.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, andBluetooth 5. The second interface optionally comprises a loudspeakerand/or a haptic feedback element for provision of an audio signal and/orhaptic feedback to the user, respectively.

The monitor device may be electrically coupled to the plurality ofelectrodes of the base plate and/or the sensor assembly part. Forexample, the monitor device may be couplable, such as releasablycouplable, to the plurality of electrodes of the base plate and/or thesensor assembly part. The monitor device may be configured to measureone or more resistances between the plurality of electrodes, and detectthe leakage of output, such as one or more indications of the leakage ofoutput, based on the measured one or more resistances.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate and/or the sensor assembly partof the ostomy appliance.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system. The docking station may be configured toelectrically and/or mechanically couple the monitor device to thedocking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

Disclosed is an ostomy system, such as an ostomy system as disclosedabove, e.g. configured to detect a leakage of output, such as one ormore indications of leakage of output between a base plate and/or asensor assembly part of the ostomy system and a surface of a subject,such as a subject wearing the base plate.

Also disclosed is a base plate a sensor assembly part and a monitordevice, as also described above. The ostomy system may comprise the baseplate, and/or the sensor assembly part, and/or a monitor device. Thebase plate and/or the sensor assembly part may be at least one ofbendable, flexible, twistable, and stretchable.

The base plate and/or the sensor assembly part includes a first adhesivelayer, such as the first adhesive layer as also described above, havinga distal surface, a proximal surface, and a first plurality of openings.The proximal surface may be configured for attachment of the base plateand/or sensor assembly part to the skin surface of a user, such as aperistomal skin surface of the user. The first adhesive layer may have astomal opening with a center point.

The base plate and/or the sensor assembly part includes an electrodeassembly, such as the electrode assembly as described above, disposed onthe distal surface of the first adhesive layer.

The electrode assembly includes a plurality of electrodes. The electrodeassembly includes a masking element between the plurality of electrodesand the first adhesive layer. The masking element has a second pluralityof openings aligned with the first plurality of openings of the firstadhesive layer to form a plurality of sensor point openings. Each of thealigned first and second plurality of openings, such as the sensor pointopenings, exposes a portion of one of the plurality of electrodes todefine one of a plurality of sensor points. The aligned first and secondplurality of openings, such as the sensor point openings, may provide aplurality of conduits at the plurality of sensor points, e.g. exposingthe portions of the plurality of electrodes.

The plurality of sensor points may comprise a plurality of sensor pointgroups, e.g. including primary sensor points, secondary sensor points,and tertiary sensor points. Each of the sensor point groups may exposesensor parts of an electrode of the plurality of electrodes. Forexample, each of the primary sensor points may include an exposedportion of a first leakage electrode, such as the ground electrode, ofthe plurality of electrodes. Each of the secondary sensor points mayinclude an exposed portion of a second leakage electrode, such as thefourth electrode, of the plurality of electrodes. Each of the tertiarysensor points may include an exposed portion of a third leakageelectrode, such as the fifth electrode, of the plurality of electrodes.The plurality of sensor points may be distributed alternatingly. Forexample, such that the nearest sensor point from a primary sensor point,such as any of the primary sensor points, is a secondary sensor pointand/or a tertiary sensor points. The nearest sensor point from a primarysensor point may not be another of the primary sensor points. In sucharrangement, two different electrodes may be exposed within the samevicinity, which facilitates the detection of the leakage of output, suchas the one or more indications of leakage of output.

The monitor device may be electrically coupled to the plurality ofelectrodes of the base plate and/or the sensor assembly part. Forexample, the monitor device may be couplable, such as releasablycouplable, to the plurality of electrodes of the base plate and/or thesensor assembly part. The monitor device may be configured to measureone or more resistances between the plurality of electrodes, and detectthe leakage of output, such as the one or more indications of leakage ofoutput based on the measured one or more resistances.

The base plate and/or the sensor assembly part may be configured todetect the leakage of output, such as the one or more indications ofleakage of output, by way of detecting short-circuit events via theplurality of electrodes. For example, a first leakage electrode and asecond leakage electrode of the plurality of electrodes can beconfigured to short-circuit through the leakage of output, e.g. when theleakage of output connects the first leakage electrode and the secondleakage electrode at a first sensor point and a second sensor point ofthe plurality of sensor points.

One of a plurality of sensor point openings, such as a first sensorpoint opening, may expose a portion of the first leakage electrode atthe first sensor point. Another of the plurality of sensor pointopenings, such as a second sensor point opening, may expose a portion ofthe second electrode at the second sensor point. Another of theplurality of sensor point openings, such as a third sensor pointopening, may expose a portion of the third electrode at a third sensorpoint. The sensor point openings provide the leakage of output a way tocontact the first, second and/or third electrodes, such as to create aless resistive pathway compared to a pathway through the first adhesivelayer. Thereby, the first, second and/or third leakage electrodes may beshort-circuited by output connecting the first sensor points and thesecond sensor point. The resistance measured between the first, secondand/or third leakage electrodes may, as a result, decrease. Decrease ofresistance between the first, second and/or third leakage electrodes maybe indicative of the less resistive pathway created by the leakage ofoutput.

The ostomy system may be configured to detect the leakage of output,such as the one or more indications of leakage of output, propagatingfrom a central region of the base plate and/or the sensor assembly parttowards any direction in a base plane, e.g. defined by the proximalsurface of the first adhesive layer. For example, the ostomy system maybe configured to detect, using the one or more resistances measured bythe monitor device via the plurality of electrodes, the leakage ofoutput and/or the one or more indications of leakage of outputpropagating from the central region of the base plate and/or the sensorassembly part towards any direction in the base plane.

The base plate and/or the sensor assembly part may comprise one or moresensing zones. The one or more sensing zones may include a first sensingzone and a second sensing zone and/or a third sensing zone. Each of theone or more sensing zones may include at least parts, such as sensingparts, of two of the plurality of electrodes.

The plurality of sensor point openings may comprise a plurality ofprimary sensor point openings in the first sensing zone. The pluralityof sensor point openings may comprise a plurality of secondary sensorpoint openings in the second sensing zone. The plurality of sensor pointopenings may comprise a plurality of tertiary sensor point openings inthe third sensing zone. The plurality of primary sensor point openingsmay comprise one or more primary first sensor point openings exposing aportion of a first leakage electrode, such as the ground electrode, ofthe plurality of electrodes. The plurality of primary sensor pointopenings may comprise one or more primary second sensor point openingsexposing a portion of a second leakage electrode, such as the fourthelectrode, of the plurality of electrodes. The plurality of secondarysensor point openings may comprise one or more secondary first sensorpoint openings exposing a portion of a third leakage electrode, such asthe fifth electrode, of the plurality of electrodes. The plurality ofsecondary sensor point openings may comprise one or more secondarysecond sensor point opening exposing a portion of the second leakageelectrode, such as the fourth electrode, of the plurality of electrodes.The plurality of tertiary sensor point openings may comprise one or moretertiary first sensor point openings exposing a portion of the thirdleakage electrode, such as the fifth electrode, of the plurality ofelectrodes. The plurality of tertiary sensor point openings may compriseone or more tertiary second sensor point opening exposing a portion ofthe first leakage electrode, such as the ground electrode, of theplurality of electrodes.

The one or more sensing zones may be distributed at least one ofcircularly, such as angularly, about, radially from, and concentricallyabout a central opening, such as a stomal opening, of the base plateand/or the sensor assembly part. For example, the one or more sensingzones may be distributed angularly about the central opening of the baseplate and/or the sensor assembly part. Alternatively or additionally,the one or more sensing zones may be distributed radially about thecentral opening of the base plate and/or the sensor assembly part.Alternatively or additionally, the one or more sensing zones may bedistributed concentrically about the central opening of the base plateand/or the sensor assembly part. Such distribution of sensing zones mayhelp detect the leakage of output and/or one or more indications ofleakage of output, such as leakage of output propagating from thecentral region of the base plate and/or the sensor assembly partoutwards to an outer region of the base plate and/or the sensor assemblypart, e.g. in any direction within the base plane. Sweat will normallybe evenly distributed underneath the base plate and/or the sensorassembly part, while output will normally be localized to a specificregion (or perhaps two neighboring regions). Thus, difference betweenmeasured values of different sensing zones may be used to differentiatebetween sweat and output.

The one or more sensing zones, such as a plurality of the one or moresensing zones, may be spaced radially and/or angularly with respect to acenter point of the stomal opening.

For example, the first sensing zone may be arranged in a first anglespace from the center point, the second sensing zone may be arranged ina second angle space from the center point, and/or the third sensingzone may be arranged in a third angle space from the center point. Thefirst angle space may span a first angle in the range from 45° to 315°,such as in the range from 45° to 135°. The second angle space may span asecond angle in the range from 45° to 315°, such as in the range from45° to 135°. The third angle space may span a third angle in the rangefrom 45° to 315°, such as in the range from 45° to 135°. The first,second, and/or third angle may depend on the number of angular sensingzones on the base plate and/or the sensor assembly part. For example,the first, second and/or third angle may be about 180°±15°, e.g. for abase plate and/or a sensor assembly part with two or more angularsensing zones. The first, second and/or third angle may be about120°±15°, e.g. for a base plate and/or a sensor assembly part with two,three or more sensing zones. The first, second and/or third angle may beabout 90°±15°, e.g. for a base plate and/or a sensor assembly part withtwo, three, four or more sensing zones.

Alternatively or additionally, the first sensing zone may be arranged ina first radial space from the center point, the second sensing zone maybe arranged in a second radial space from the center point, and/or thethird sensing zone may be arranged in a third radial space from thecenter point. The first radial space may span a primary radius in therange from 5-50 mm, such as in the range from 10-25 mm, such as in therange from 13-14 mm. The second radial space may span a second radius inthe range from 10-50 mm, such as in the range from 10-25 mm, such as inthe range from 25-26 mm. The third radial space may span a third radiusin the range from 15-50 mm, such as in the range from 25-50 mm, such asin the range from 29-30 mm. The first, second and/or third radius maydepend on the number of radial sensing zones on the base plate and/orthe sensor assembly part. The second radius may be greater than thefirst radius. The third radius may be greater than the second radiusand/or the first radius.

Each of the one or more sensing zones may include at least sensing partsof two of the plurality of electrodes, e.g. such that each of the one ormore sensing zones may be generally defined, outlined, designated,and/or specified by two of the plurality of electrodes. For example, thefirst leakage electrode and the second leakage electrode, such as theground electrode and the fourth electrode, of the plurality ofelectrodes may define the first sensing zone. Alternatively oradditionally, the second leakage electrode and the third leakageelectrode, such as the fourth electrode and the fifth electrode, of theplurality of electrodes may define the second sensing zone.Alternatively or additionally, the first leakage electrode and the thirdleakage electrode, such as the ground electrode and the fifth electrode,of the plurality of electrodes may define the third sensing zone. One ormore of the plurality of electrodes may be in a plurality of the one ormore sensing zones.

The one or more sensing zones may include a fourth sensing zone and/or afifth sensing zone and/or a sixth sensing zone. For example, the firstleakage electrode and a fourth leakage electrode, such as the groundelectrode and a sixth electrode, of the plurality of electrodes maydefine the fourth sensing zone. Alternatively or additionally, thesecond leakage electrode and the fourth leakage electrode, such as thefourth electrode and the sixth electrode, of the plurality of electrodesmay define the fifth sensing zone. Alternatively or additionally, thefourth leakage electrode and the third leakage electrode, such as thesixth electrode and the fifth electrode, of the plurality of electrodesmay define the sixth sensing zone.

Each of the one or more sensing zones may include at least sensing partsof two of the plurality of sensor point groups, wherein each of the twoof the plurality of sensor point groups exposes portions of one of theplurality of electrodes. For example, the first sensing zone maycomprise some of the primary sensor points and some of the secondarysensor points. The second sensing zone may comprise some of thesecondary sensor points and some of the tertiary sensor points. Thethird sensing zone may comprise some of the primary sensor points andsome of the tertiary sensor points.

The first adhesive layer may have a first electrical conductivity. Themasking element may have a second electrical conductivity. Output mayhave a third electrical conductivity. The second electrical conductivitymay be lower than the first electrical conductivity. Alternatively oradditionally, the third electrical conductivity may be higher than thefirst electrical conductivity.

The first adhesive layer may be air permeable, such as at least slightlyair permeable, e.g. to help the leakage of output enter the plurality ofconduits at the plurality of sensor points with minimal resistivepressures created by the leakage of output compressing the air in theplurality of conduits. The plurality of conduits may be configured forthe leakage of output to easily enter such that the ostomy system mayregister the leakage signal, e.g. by detecting the short-circuit event,less than 1 second from the leakage of output entering the correspondingsensing zone.

The masking element may comprise at least one of polymeric and ceramicmaterials. For example, the masking element may comprise polymericmaterials. Alternatively or additionally, the masking element maycomprise ceramic materials.

The plurality of electrodes may comprise at least one of metallic,ceramic, polymeric, and carbonaceous materials. For example, theplurality of electrodes may comprise metallic materials. Alternativelyor additionally, the plurality of electrodes may comprise ceramicmaterials. Alternatively or additionally, the plurality of electrodesmay comprise polymeric materials. Alternatively or additionally, theplurality of electrodes may comprise carbonaceous materials. Theplurality of electrodes may comprise one of silver and carbon. Forexample, the plurality of electrodes may comprise silver. Alternativelyor additionally, the plurality of electrode may comprise carbon.

The base plate and/or the sensor assembly part may comprise, such asfurther comprise, a second adhesive layer. The second adhesive layer maybe coupled distally to the first adhesive layer and the electrodeassembly. For example, the second adhesive layer may be attached to thedistal side of the electrode assembly and/or first adhesive layer. Thesecond adhesive layer may be at least one of more adhesive to thesurface of the subject, more moisture permeable, lessmoisture-absorbent, and lower in moisture capacity than the firstadhesive layer. For example, the second adhesive layer may be moreadhesive to the surface of the subject than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be moremoisture permeable than the first adhesive layer. Alternatively oradditionally, the second adhesive layer may be less moisture-absorbentthan the first adhesive layer. Alternatively or additionally, the secondadhesive layer may have a lower moisture capacity than the firstadhesive layer. The adhesive properties may be selected to obtaindesired sensing range, sensing responsiveness, adhesive security, and/orprolonged usable time of the base plate.

The base plate and/or the sensor assembly part may comprise, such asfurther comprise, a release liner. The release liner may be releasablyattached to a proximal surface of the first adhesive layer. The releaseliner may have a plurality of protrusions configured to extend into thefirst plurality of openings of the first adhesive layer. The pluralityof protrusions of the release liner may preserve the openings in thefirst adhesive layer, since the first adhesive layer may exhibit viscousproperties. Thereby, shelf life of the base plate and/or the sensorassembly part may be extended.

The base plate and/or the sensor assembly part may comprise, such asfurther comprise, a first intermediate element, e.g. between the firstadhesive layer and a plurality of connection parts of the plurality ofelectrodes. The first intermediate element may be between the firstadhesive layer and the plurality of connection parts to shield theconnections parts from the first adhesive layer. For example, theelectrical conductivity may change as a function of moisture content inthe first adhesive layer. Thus, shielding the connection parts from thefirst adhesive layer may decrease the change in conductivity betweenelectrodes caused by changing moisture content of the first adhesivelayer near the connection parts.

The first intermediate element may be less electrically conductive thanthe first adhesive layer, e.g. such that the resistance measurement isnot influenced by the first intermediate element near the connectionparts of the plurality of electrodes.

The electrode assembly may further comprise a support layer coupled tothe plurality of electrodes, e.g. to provide additional structuralintegrity for the electrode assembly that includes the plurality ofelectrodes. For example, the plurality of electrodes may have beenprinted onto the support layer. The support layer may have a greaterstructural integrity than the first adhesive layer. For example, thesupport layer may be less stretchable than the first adhesive layer.

The first adhesive layer and/or the second adhesive layer may comprise ahydrocolloid and/or a polymer matrix, e.g. such that the first adhesivelayer and/or the second adhesive layer is moisture absorbent.

The first adhesive layer may have a smaller surface coverage than thesecond adhesive layer. The first adhesive layer and/or the secondadhesive layer may have bigger surface coverage than the plurality ofelectrodes and/or the electrode assembly. Thereby, the plurality ofelectrodes and/or the electrode assembly may be encapsulated byadhesive, e.g. the first adhesive layer and the second adhesive layer,and the first adhesive layer and the second adhesive layer may beattached along a rim portion of the first adhesive layer and/or thesecond adhesive layer.

The monitor device may be configured to generate a leakage signal, e.g.when the leakage of output is detected and/or when the one or moreindications of the leakage of output is detected, such as detected in atleast one of the one or more sensing zones.

The monitor device may be configured to determine rate of change of eachof the one or more resistances measured in the one or more sensingzones. For example, the monitor device may be configured to determine afirst rate of change of the first resistance measured in the firstsensing zone, the monitor device may be configured to determine a secondrate of change of the second resistance measured in the second sensingzone, and/or the monitor device may be configured to determine a thirdrate of change of the third resistance measured in the third sensingzone. The rate of change may be different depending on the cause of thechange, e.g. whether the change is caused by output or sweat. Themonitor device may be configured to generate the leakage signal based onthe determined rate of change, such as the first, second and/or thirdrate of change. The rate of change may be indicative of a presumed causeof the change of resistance in the one or more sensing zone, such as thefirst, second and/or third sensing zone. The monitor device may beconfigured to generate the leakage signal if the determined rate ofchange is above a first rate threshold. The monitor device may beconfigured to forgo generation of the leakage signal if the determinedrate of change is below a second rate threshold. The first ratethreshold may be the same as the second rate threshold. Alternatively,the first rate threshold may be greater than the second rate threshold.

It may be useful to introduce an instant relative decay (IRD) in orderto differentiate leakage from moisture absorption. The IRD is equal tothe difference (typically a fall in resistance, i.e. a decay) between ameasured data point (e.g. a numerical value of the resistance across asensor) and the previously measured data point (e.g. another numericalvalue of the resistance across a sensor), divided by the maximumpossible difference (decay). The maximum decay may be the situationgoing from a baseline measurement of a healthy base plate and/or sensorassembly part, to a situation where the resistance has fallen to zero,i.e. indicative of a short-circuited sensor. Thus, the instant relativedecay (IRD) is given by;

${IRD} = {\frac{{A_{2} - A_{1}}}{A_{m\;{ax}}} \times 100\%}$where A₂ and A₁ are the previously measured data point (at time t₂) andthe present data point (at time t₁), respectively, and where Amax is thelargest possible decay. For resistance measurements, Amax may be theabsolute value of the resistance across a sensor in a healthy base plateand/or sensor assembly part. The difference A₂-A₁ may be denominated anactual decay, as it relates to the decay in the measured parameter atpresent relative to the previously measured value of the parameter.Preferably, the modulus (absolute value) of the actual decay isconsidered.

The monitor device and/or the accessory device may be configured todetermine an instant relative decay based on the measured resistancemeasured across the one or more sensors and/or in the one or moresensing zones. Therefrom, the monitor device and/or the accessory devicemay be configured to determine the condition of the base plate/and orthe sensor assembly part.

It should be noted that other parameters than resistance may bemonitored, as described previously. Further, it should be noted that theformula does not require a certain unit (for resistance measurements;ohm), as only a relative change is considered. As such, a signalproportional to the resistance across the sensor is sufficient tocalculate the IRD.

The data point sampling rate may be from 1 Hz (every second) to 0.017 Hz(every 60th second), or even higher or lower, depending on the settingsof the monitor device and/or the accessory device. A higher samplingrate results in a higher power usage. Thus, the difference t₂-t₁ maycorrespond the interval between consecutively measured data pointsaccording to the given data point sampling rate. The data point samplingrate may be adaptive to the condition of the base plate and/or thesensor assembly plate. For example, the sampling rate may be increasedif a tendency of increasing IRD is observed. Thereby, power is savedwhen the base plate and/or the sensor assembly part is consideredhealthy, and may instead be directed to the situation where the baseplate and/or the sensor assembly part is deteriorating.

The monitor device and/or the accessory device may determine/calculatethe IRD based on the measured raw data. Alternatively, the monitordevice and/or the accessory device may determine/calculate a movingaverage based on the measured raw data prior to determining/calculatingthe IRD. Thus, the monitor device/and or the accessory device maydetermine/calculate the IRD based on the moving average of the raw data.The moving average may be an exponential moving average or a simplemoving average. Introducing a moving average serves to reduce thesignificance of false signals. From the moving average, the monitordevice and/or the accessory device may determine/calculate thederivative, which emphasizes changes in the measured data points, i.e.changes in the resistance. The monitor device and/or the accessorydevice may determine/calculate the IRD from the derivative of thecalculated moving average.

The IRD allows for a mathematical treatment and differentiation ofleakage and moisture absorption. In particular, the IRD allows for thedifferentiation of leakage and expel of sweat. A threshold of 60%, of70%, of 80%, or of 90% may be introduced to specify leakage. Thethreshold may be adaptive to the individual user, such that a lower orhigher percentage may be used as the threshold to define a leakage. Asan example, an IRD of 80% indicates an instant drop in resistance of80%, which may indicate a sudden presence of output, i.e. a leakage. Incase the threshold is set at 80%, the calculated IRD of more than, orequal to, 80% is considered leakage of output, whereas an IRD of lessthan 80% is considered moisture absorption, e.g. resulting from anexcessive expel of sweat. Thus, the monitor device and/or the accessorydevice may determine whether a calculated IRD falls below or above athreshold value. The monitor device and/or the accessory device may beconfigured to generate a leakage signal if the calculated IRD is abovethe threshold value.

In the case of an electrode assembly divided into sensing zones, theabove discussed mathematical process of differentiating a leakage frommoisture absorption or expel of sweat may be applied to each sensingzone. Thus, the monitor device and/or the accessory device may beconfigured to determine/calculate the IRD for each of the one or moresensing zones of the base plate and/or sensor assembly part. Likewise,the derivative of the moving average may be used to monitor the healthof the baser plate and/or the sensor assembly part by analysing thechanges of resistance. Thus, the monitor device and/or the accessorydevice may be configured to apply the derivative to a forecast model forforecasting the health of the base plate and/or the sensor assemblypart.

A leakage signal may comprise at least one of leakage location, leakagepropagating direction, and leakage propagating velocity. The leakagelocation may comprise the sensing zones where short-circuit events havebeen detected. Additionally, the leakage location may comprise a regionbetween the sensing zones where the short-circuit events have beendetected.

The leakage propagating direction may comprise a direction from one ofthe one or more sensing zones that first registered a short-circuitevent, to another of the one or more sensing zones that next registereda short-circuit event. The leakage propagating direction may besubstantially parallel to the base plate and/or the sensor assembly partand/or the base plane. The leakage propagating velocity may comprise avelocity derived by dividing the distance between the two sensing zoneswhere short-circuit events have sequentially been detected, by atime-delay between the detection of short-circuit events at the twosensing zones.

Leakage of output may be detected, e.g. one or more indications ofleakage of output may be detected, e.g. based on the measured one ormore resistances. The detection of leakage of output, such as detectionof one or more indications of leakage of output, may comprisedetermining that the leakage of output is present, e.g. when one or moreof the one or more resistances measured, e.g. at one or more of the oneor more sensing zones, is smaller or equal to one of one or morethreshold resistances. Different threshold resistances may be employedfor different sensing zones, e.g. to reflect different electrodecharacteristics such as length or inter-electrode spacing. For example,a first threshold resistance may be employed for the first sensing zone,a second threshold resistance may be employed for the second sensingzone, and/or a third threshold resistance may be employed for the thirdsensing zone.

The ostomy system may be configured to provide warning to the user basedon the detection of leakage of output, such as detection of one or moreindications of leakage of output, e.g. such that the base plate may bereplaced before the leakage of output exits the containment of theostomy appliance, such as the base plate.

Also disclosed is a method of detecting a leakage of output, such asdetection of one or more indications of leakage of output, between abase plate and/or the sensor assembly part of an ostomy system and asurface of a subject, such as a subject wearing the base plate and/orthe sensor assembly part.

The ostomy system may be the ostomy system as disclosed above. Forexample, the ostomy system includes the base plate and/or the sensorassembly part and a monitor device. The base plate and/or the sensorassembly part comprises (i) a first adhesive layer having a distalsurface, a proximal surface, and a first plurality of openings, theproximal surface may be configured for attachment of the base plate tothe skin surface of a user, and (ii) an electrode assembly comprising aplurality of electrodes and a masking element between the plurality ofelectrodes and the first adhesive layer. The masking element has asecond plurality of openings aligned with the first plurality ofopenings of the first adhesive layer, e.g. to form a plurality of sensorpoint openings. Each of the aligned first and second plurality ofopenings, such as the plurality of sensor point openings, exposes aportion of one of the plurality of electrodes to define one of aplurality of sensor points. The monitor device is electrically coupledand/or couplable, such as releasably couplable, to the plurality ofelectrodes of the base plate and/or the sensor assembly part.

The method may comprise measuring, e.g. via the plurality of electrodes,one or more resistances. Each of the one or more resistances measuredbetween two of the plurality of electrodes. The method may comprisedetecting the leakage of output, such as detecting one or moreindications of leakage of output, based on the measured one or moreresistances.

Measuring one or more resistances, e.g. between the plurality ofelectrodes, may comprise measuring each of the one or more resistancesin one of one or more sensing zones. The one or more sensing zones mayinclude a first sensing zone, a second sensing zone and/or a thirdsensing zone.

Measuring one or more resistances, e.g. between the plurality ofelectrodes, may comprise measuring each of the one or more resistancesbetween two of the plurality of electrodes, wherein portions of each ofthe two of the plurality of electrodes are exposed by some of aplurality of conduits, such as the sensor point openings, at some of theplurality of sensor points of the same sensing zone, such as the firstsensing zone, the second sensing zone and/or the third sensing zone.

Measuring one or more resistances, e.g. between the plurality ofelectrodes, may comprise measuring a first resistance in a first sensingzone and measuring a second resistance in a second sensing zone.Measuring one or more resistances, e.g. between the plurality ofelectrodes, may comprise measuring a third resistance in a third sensingzone. The first resistance may be measured between a first leakageelectrode, such as a ground electrode, and a second leakage electrode,such as a fourth electrode, of the plurality of electrodes. The firstleakage electrode, such as the ground electrode, may be exposed at afirst sensor point in the first sensing zone. The second leakageelectrode, such as the fourth electrode may be exposed at a secondsensor point in the first sensing zone. The second resistance may bemeasured between the second leakage electrode, such as the fourthelectrode, and a third leakage electrode, such as a fifth electrode ofthe plurality of electrodes. The second leakage electrode, such as thefourth electrode, may be exposed at a third sensor point in the secondsensing zone. The third leakage electrode, such as the fifth electrodemay be exposed at a fourth sensor point in the second sensing zone. Thefirst resistance may be measured between the first leakage electrode,such as the ground electrode and the third leakage electrode, such asthe fifth electrode, of the plurality of electrodes. The first leakageelectrode, such as the ground electrode may be exposed at a fifth sensorpoint in the third sensing zone. The third leakage electrode, such asthe fifth electrode may be exposed at a sixth sensor point in the thirdsensing zone.

Measuring one or more resistances, e.g. between the plurality ofelectrodes, may comprise measuring each of the one or more resistancesin one of one or more sensing zones between two of the plurality ofelectrodes, wherein portions of each of the two of the plurality ofelectrodes are exposed by some of a plurality of conduits, such as ofthe plurality of sensor point openings, at some of the plurality ofsensor points such that the leakage of output may contact both of thetwo of the plurality of electrodes by entering two or more of theplurality of conduit, such as of the plurality of sensor point openings,s to create a less resistive path for measuring resistance between thetwo of the plurality of electrodes.

The measuring, between the plurality of electrodes, one or moreresistances may comprise measuring each of the one or more resistancesin one or more sensing zones including a first sensing zone and a secondsensing zone. A first resistance of the one or more resistances may bemeasured for the first sensing zone and a second resistance of the oneor more resistances may be measured for the second sensing zone. Thefirst resistance may be measured between two of the plurality ofelectrodes being exposed by some of a plurality of conduits, such as ofthe plurality of sensor point openings, at some of the plurality ofsensor points in the first sensing zone. The second resistance may bemeasured between two of the plurality of electrodes being exposed bysome of the plurality of conduits, such as of the plurality of sensorpoint openings, at some of the plurality of sensor points in the secondsensing zone.

Detecting the leakage of output, such as detecting one or moreindications of leakage of output, e.g. based on the measured one or moreresistances, may comprise determining that the leakage of output ispresent, e.g. when one or more of the one or more resistances measured,e.g. at one or more of one or more sensing zones, is smaller or equal toone of one or more threshold resistances. Different thresholdresistances may be employed for different sensing zones, e.g. to reflectdifferent electrode characteristics such as length or inter-electrodespacing. For example, a first threshold resistance may be employed forthe first sensing zone, a second threshold resistance may be employedfor the second sensing zone, and/or a third threshold resistance may beemployed for the third sensing zone.

The method may further comprise generating a leakage signal, e.g.through the monitor device when the leakage of output has been detected,such as when the one or more indications of leakage of output has beendetected.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4. The base plate4 is adapted to support an ostomy pouch (not shown). Further, the ostomysystem 1 comprises a monitor device 6 and an accessory device 8 (mobiletelephone). The monitor device 6 is connectable to the base plate 4 viarespective first connectors of the monitor device 6 and base plate 4.The monitor device 6 is configured for wireless communication with theaccessory device 8. Optionally, the accessory device 8 is configured tocommunicate with a server device 10 of the ostomy system 1, e.g. vianetwork 12. The server device 10 may be operated and/or controlled bythe ostomy appliance manufacturer and/or a service centre. Ostomy dataor parameter data based on the ostomy data are obtained fromelectrodes/sensors of the ostomy appliance 2 with the monitor device 6.The monitor device 6 processes the ostomy data and/or parameter databased on the ostomy data. Based on the processed ostomy data, themonitor device 6 may determine what monitor data that are transmitted tothe accessory device 8. In the illustrated ostomy system, the accessorydevice 8 is a mobile phone, however the accessory device 8 may beembodied as another handheld device, such as a tablet device, or awearable, such as a watch or other wrist-worn electronic device.Accordingly, the monitor device 6 is configured to determine andtransmit monitor data to the accessory device 8. The base plate 4comprises a coupling member 14 in the form of a coupling ring 16 forcoupling an ostomy pouch (not shown) to the base plate (two-part ostomyappliance). The base plate has a stoma-receiving opening 18 with a stomacenter point. The size and/or shape of the stomal opening 18 aretypically adjusted by the user or nurse before application of the ostomyappliance to accommodate the user's stoma. The base plate may have acentral region 400 and an outer region 404. The central region 400 isthe region near the stomal opening 18 and/or substantially equal to theregion within the coupling member 14. The outer region 404 is the regionfarther from the stomal opening 18 and/or substantially equal to theregion outside of the coupling member 14.

The ostomy system 1 optionally comprises a docking station 20 forming analternative/additional accessory device of the ostomy system 1. Thedocking station 20 comprises a docking monitor interface including afirst connector 22 configured for electrically and/or mechanicallyconnecting the monitor device 6 to the docking station 20. The dockingmonitor interface may be configured for wirelessly connecting themonitor device to the docking station. The docking station 20 comprisesa user interface 24 for receiving user input and/or providing feedbackto the user on the operational state of the docking station 20. The userinterface 24 may comprise a touch-screen. The user interface 24 maycomprise one or more physical buttons and/or one or more visualindicators, such as light emitting diodes.

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor 101and one or more interfaces, the one or more interfaces including a firstinterface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 comprises a ground terminal 108, a first terminal110, a second terminal 112 and a third terminal 114. The first interface102 optionally comprises a fourth terminal 116 and a fifth terminal 118.The first interface 102 of the monitor device 6 comprises a couplingpart 120 for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate. The couplingpart 120 and the terminals 108, 110, 112, 114, 116, and 118 of the firstinterface 102 form (at least part of) a first connector of the monitordevice 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 optionally comprises a sensor unit 140 connected tothe processor 101. For example, the sensor unit 140 comprises atemperature sensor for feeding temperature data to the processor and/ora G-sensor or accelerometer for feeding acceleration data to theprocessor 101. Additionally or alternatively, the sensor unit 140comprises a humidity sensor and/or an acoustic sensor. The sensor unit140 may comprise alternative and/or additional sensors suitable and/orrelevant to an ostomy system as described.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate and/or the sensor assembly part coupled to the firstinterface, the ostomy data comprising first ostomy data from a firstelectrode pair of the base plate and/or the sensor assembly part, secondostomy data from a second electrode pair of the base plate and/or thesensor assembly part, and third ostomy data from a third electrode pairof the base plate and/or the sensor assembly part. The ostomy data maybe stored in the memory 106 and/or processed in the processor 101 inorder to obtain parameter data. The parameter data may be stored in thememory 106. The processor 101 is configured to apply a processingscheme, wherein to apply a processing scheme comprises obtain firstparameter data based on the first ostomy data; obtain second parameterdata based on the second ostomy data; obtain third parameter data basedon the third ostomy data. In other words, the processor 101 isconfigured to obtain first, second and third parameter data based onrespective first, second and third ostomy data. To apply a processingscheme comprises to determine an operating state of the base plateand/or the sensor assembly part of the ostomy appliance based on one ormore, e.g. all, of the first parameter data, the second parameter dataand the third parameter data, wherein the operating state is indicativeof a degree of radial erosion of the base plate and/or the sensorassembly part and/or acute leakage risk for the ostomy appliance. Themonitor device 6 is configured to, in accordance with a determinationthat the operating state is a first operating state, transmit a firstmonitor signal comprising monitor data indicative of the first operatingstate of the base plate and/or the sensor assembly part via the secondinterface; and in accordance with a determination that the operatingstate is a second operating state, transmit a second monitor signalcomprising monitor data indicative of the second operating state of thebase plate and/or the sensor assembly part via the second interface.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200.During use, a proximal surface of the first adhesive layer 200 adheresto the user's skin in the peristomal area and/or to additional seals,such as sealing paste, sealing tape and/or sealing ring. The base plate4 optionally comprises a second adhesive layer 202, also denoted rimadhesive layer. The base plate 4 comprises a plurality of electrodesarranged in an electrode assembly 204. The electrode assembly 204 isarranged between the first adhesive layer 200 and the second adhesivelayer 202. The electrode assembly 204 comprises a support layer withelectrodes formed on a proximal surface of the support layer. The baseplate 4 comprises a release liner 206 that is peeled off by the userprior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 and a coupling ring 209 for coupling an ostomypouch to the base plate 4. The top layer 208 is a protective layerprotecting the second adhesive layer 202 from external strains andstress during use.

As illustrated in FIG. 3 , the plurality of electrodes 216, which may bepart of an electrode assembly 204 (see FIG. 4 ), may be arranged betweenthe first and second adhesive layers 200, 202. Each of the firstadhesive layer 200, second adhesive layer 202, and the electrodeassembly 204 has a central opening 18 a, 18 b, 18 c, respectively. Thecentral openings 18 a, 18 b, 18 c are aligned to define a centralopening 18 (may also be denoted as the stoma-receiving opening) of thebase plate 4. The central opening 18 is configured to fit around thestoma of the user. In embodiments, one or more of the central openings18 a, 18 b, 18 c may be absent, thus requiring the central missingopening(s) to be created before use (e.g. by the user).

In embodiments, the base plate 4 may comprise a top film 208 disposeddistally to the second adhesive layer 202 and/or first adhesive layer200. The top film 208 may provide protection to the rest of the baseplate (e.g. except for the first connector 211 and the coupling ring209) from being mechanically damaged (e.g. during handling and applyingof the base plate 4) and/or chemically attacked (e.g. by the output,which may be acidic). A proximal surface 208B of the top film 208 may becoupled to a distal surface 202A of the second adhesive layer 202. Inembodiments, a distal surface 208A of the top film 208 is substantiallysmooth thus prevents the base plate 4 from sticking to or damaging theclothing of the user.

According to embodiments, at least part of the base plate 4 may be oneof bendable, flexible, twistable, and stretchable, e.g. to help improvecoupling conformity and/or security of the adhesion between the baseplate 4 and the surface of the subject.

In embodiments, the first and/or second adhesive layers 200, 202comprise hydrocolloid (e.g. cellulose, alginate) and polymer matrix(e.g. SIS) materials such that the adhesive layers 200, 202 are bothadhesive to the surface of the subject (e.g. skin of the patient) andmoisture absorbent (e.g. absorbent of the moisture of sweat and output),e.g. in addition to being at least one of bendable, flexible, twistable,and stretchable.

In embodiments, the first adhesive layer 200 and the second adhesivelayer 202 comprise adhesive materials adhesive to each other, enablingthe two adhesive layers 200, 202 be adhered by pressing them togetherwith or without heating. In embodiments, the adhesive strength to thesurface of the user may be reduced with increasing moisture content inthe first and second adhesive layers 200, 202, while the electricalconductivity increases with increasing moisture content in the first andsecond adhesive layers 200, 202.

In embodiments, the first adhesive layer 200 may have a smaller surfacecoverage than the second adhesive layer 202, while both the first andthe second adhesive layers 200, 202 having bigger surface coverage thanthe plurality of electrodes 216 and the electrode assembly 204. Thereby,the plurality of electrodes 216 and the electrode assembly 204 may beencapsulated by adhesive, e.g. by the first adhesive layer 200 and thesecond adhesive layer 202.

For example, a proximal side 200B of the first adhesive layer 200 isconfigured to be attached to the skin of the patient and surround thestoma of the patient. The plurality of electrodes 216 of the electrodeassembly 204, which may have a smaller surface coverage than the firstadhesive layer 200, may be coupled to a distal side 200A of the firstadhesive layer 200, leaving at least a rim portion of the distal surface200A of the first adhesive layer 200 exposed. The second adhesive layer202 may be distally coupled to the plurality of electrodes 216 or theelectrode assembly 204 at a central region 400 (see FIG. 1 ) of the baseplate 4. The second adhesive layer 202, which has larger surfacecoverage than the electrode assembly 204 and the plurality of electrodes216, may further be distally coupled to the first adhesive layer 200 atleast at the rim portion of the distal surface 200A of the firstadhesive layer 200, leaving a rim portion of a proximal surface 202B ofthe second adhesive layer 202 exposed. The exposed rim of the proximalsurface 202B of the second adhesive layer 202 may be configured to beattached to the skin of the patient at an outer region 404 (see FIG. 1 )of the base plate 4 and surround the first adhesive layer 200. Forexample, the central region 400 of the base plate 4 may be substantiallythe same size as the electrode assembly 204 or the plurality ofelectrodes 216.

In embodiments, the difference in surface coverage between the first andsecond adhesive layers 200, 202 may be designed to feature the differentadhesive properties of the first and second adhesive layers 200, 202.For example, the first adhesive layer 200 may possess higher moisturecapacity and higher moisture absorbability than the second adhesivelayer 202; whereas the second adhesive layer 202 may possess highermoisture permeability and higher adhesive strength to the surface of thesubject than the first adhesive layer 202. In embodiments, adhesiveproperties of the first and second adhesive layers 200, 202 may beadjusted by adjusting the hydrocolloid-to-polymer compositional ratio.For example, increasing the hydrocolloid-to-polymer compositional ratiomay increase moisture capacity and absorbability but may also decreasemoisture permeability and adhesive strength to the surface of thesubject.

In embodiments, the correlation between adhesive strength, moisturecontent, and electrical conductivity of the first adhesive layer 200 maybe useful to how the ostomy system may be configured to detect and/orestimate moisture content in the first adhesive layer 200 by measuringelectrical conductivity, by way of measuring resistances between theplurality of electrodes 216. Through the moisture content estimatedand/or detected, the ostomy system may further provide informationregarding whether the first adhesive layer 200 has detached from theskin of the patient. More detailed description on moisture and leakageof output sensing is provided in later paragraphs.

In embodiments, the first adhesive layer 200, being disposed between theplurality of electrodes 216 and the skin of the patient, may be designedto have a higher moisture capacity than, e.g. the second adhesive layer202, e.g. to provide the ostomy system with a larger sensing range inmoisture content. The first adhesive layer 200 may also possess a highermoisture absorbability than e.g. the second adhesive layer 202, e.g. tohelp increase sensing responsiveness to changes in moisture content nearthe stoma of the user, which would also effectively reduce problems suchas skin irritation and swelling, as well as pre-mature detachment of thefirst adhesive layer 200 from the skin of the user.

In embodiments, the second adhesive layer 202, being configured to becoupled to the skin of the patient at the outer region 404 of the baseplate 4 surrounding the first adhesive layer 200, may be designed tohigher adhesive strength to the surface, e.g. skin, of the patient toreduce risk of detachment of the base plate 4 from the skin of thepatient. This helps the base plate 4 to stay attached to the skin of thepatient even when the first adhesive layer 200 has completely detachedfrom the surface of the subject. This provides extra protection againstleakage of output undesirably exiting the containment of the ostomyappliance, such as the base plate 4. The second adhesive layer 202 maybe further designed to have the higher moisture permeability than e.g.the first adhesive layer 200, e.g. to help the absorbed moisture in thesecond adhesive layer 202 to exit the second adhesive layer 202 quicker,e.g. to maintain sufficiently high adhesive strength to the surface ofthe patient. This further enhances the attachment security of the baseplate on the skin of the patient.

The release liner 206 may be releasably attached to the proximal surface200A of the first adhesive layer 200 and configured to be peeled off(e.g. by the user) prior to applying the base plate 4 onto the skin. Therelease liner 206 may comprise a plurality of protrusions 207 arrangedto extend through the first plurality of openings 259 of the firstadhesive layer 200 when the release liner 206 is releasably attached tothe proximal surface 200A of the first adhesive surface 200. Theplurality of protrusions 207 helps retain the first plurality ofopenings 259 of the first adhesive layer 200 by inhibiting the adhesivematerial from creeping and closing the first plurality of openings 259.This may in particular be relevant when the first adhesive layer 200have viscoelastic properties and/or have the tendency to deformplastically when stressed mechanically and/or heated.

In embodiments, the first adhesive layer 200 has a plurality of sensorpoint openings, which may be denoted as the first plurality of openings259 of the first adhesive layer 200. The purpose of the sensor pointopening is described in detail below (see e.g. FIG. 8 ).

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the proximalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer 200. The first intermediate element 213 covers theterminal elements forming terminals 212 of the base plate 4 when seen inthe axial direction and protects the first adhesive layer frommechanical stress from the terminal elements of the base plate.

As previously described, some parts of the illustrated base plate 4, maybe provided as a separate assembly to be applied to an existing baseplate, e.g. comprising one or more of the components as described, suchas to provide a base plate like the base plate 4 as described. Forexample, a sensor assembly part 700 may be provided, e.g. comprising theelectrode assembly 204, the first connector 211, the first intermediateelement 213, the first adhesive layer 200 and the release liner 206.Additionally, the sensor assembly part 700 may also comprise the secondadhesive layer 202 and/or the top layer 208. It may be envisioned thatthe user may provide a hole in layers of the base plate whereto thesensor assembly part 700 is to be applied, to allow for the firstconnector 211 of the sensor assembly part 700 to protrude through layersof the base plate whereto the sensor assembly part 700 is applied.Alternatively, the sensor assembly part 700 may be applied to the baseplate such that the first connector 211 is positioned outside theperiphery of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate and/or a sensor assembly part. The electrodeassembly 204 comprises a support layer 214 with proximal surface 214Band electrodes 216 arranged on the proximal side of the support layer214 and including a ground electrode, a first electrode, a secondelectrode, a third electrode, a fourth electrode, and a fifth electrode,wherein each electrode has a respective connection part for connectingthe electrodes to respective terminal elements of the monitor interface.Further, electrode assembly 204 comprises a masking element 218 withproximal surface 218B and configured to insulate electrode parts ofelectrodes 216 from the first adhesive layer of the base plate and/or asensor assembly part. The masking element 218 covers or overlaps withparts of the electrodes 216 when seen in the axial direction.

As illustrated in FIG. 4 , the masking element 218 may include aplurality of sensor point openings, which may also be denoted as asecond plurality of openings 253 (see FIG. 7 ). Each of the secondplurality of openings 253 may be arranged to expose a portion of one ofthe plurality of electrodes 216. The masking element 218 may also beconfigured to expose the connection parts 221 of the plurality ofelectrodes 216. The masking element 218 may shield the covered parts ofthe plurality of electrodes 216 from the first adhesive layer 200 andmay have lower electrical conductivity than the first adhesive layer 200to avoid creating a less resistive pathway (e.g. through the maskingelement 218) between any two of the plurality of electrodes 216 thanthrough the first adhesive layer 200. This may improve the accuracy ofcorrelating the measured resistance between any two of the plurality ofelectrodes 216 to the leakage of output.

In embodiments, the plurality of electrodes 216 may comprise at leastone of metallic (e.g. silver, copper, gold, titanium, aluminium,stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy),and carbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials. The masking element may comprise at leastone of polymeric (e.g. polyurethane, PTFE, PVDF) and ceramic (e.g.alumina, silica) materials.

In embodiments, the plurality of electrodes 216 may be prepared byscreen-printing, inkjet-printing, direct-ink-writing, pen-plotting,3D-printing, fused-deposition-modelling, contact-transfer printing,spray painting, chemical vapour depositing, physical vapour depositing,atomic-layer-depositing, wire-bending, and any other methods known to aperson skilled in the art. The plurality of electrodes 216 may furtherrequire one of heat-curing, UV-curing, and oxygen-activating.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate and/or a sensor assembly part without the first adhesivelayer and the release liner. The base plate 4 and/or a sensor assemblypart 700 comprises a first intermediate element 213 on the proximal sideof the electrode assembly, i.e. between the electrode assembly 204 andthe first adhesive layer (not shown). The first intermediate element 213covers the terminal elements of the base plate 4 when seen in the axialdirection and protects the first adhesive layer from mechanical stressfrom the terminal elements of the base plate and/or a sensor assemblypart.

In embodiments, the first intermediate element 213 may prevent theplurality of terminals 212 of the monitor interface from contacting thefirst adhesive layer 200 (see FIG. 3 ). In embodiments, the firstintermediate element 213 has an electrical conductivity lower than thatof the first adhesive layer 200 to avoid creating a less resistivepathway (e.g. through the first intermediate element 213) than throughthe first adhesive layer 200 e.g. through the first adhesive layer atthe one or more sensing zones 251 (see FIG. 11 ). Consequently, theconnection parts 221 (see FIG. 4 ), shielded by the first intermediateelement 213, may be non-responsive to the increased electricalconductivity of the first adhesive layer 200 when moisture has beenabsorbed. This helps to more accurately measure moisture content at theone or more sensing zones 251 (see FIG. 11 ) by the plurality ofelectrodes 216. The first intermediate element 213 may also strengthenthe structural integrity of the base plate 4 at least near theconnection parts 221.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrode assembly204, such as the electrode configuration 220 of the electrode assembly204 comprises a ground electrode 222, a first electrode 224, a secondelectrode 226, a third electrode 228, a fourth electrode 230, and afifth electrode 232. The electrodes 216 comprise connection parts 221.The ground electrode 222 comprises a ground connection part 222A and thefirst electrode 224 comprises a first connection part 224A. The secondelectrode 226 comprises a second connection part 226A and the thirdelectrode 228 comprises a third connection part 228A. The fourthelectrode 230 comprises a fourth connection part 230A and the fifthelectrode 232 comprises a fifth connection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifthelectrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 234 forforming a ground for the first electrode 224. The ground electrode 222comprises a second electrode part 236 for forming a ground for thesecond electrode 226. The ground electrode 222 comprises a thirdelectrode part 238 for forming a ground for the third electrode 228. Theground electrode 222 comprises a fourth electrode part 240 for forming aground for the fourth electrode 230 and the fifth electrode 232. Thefourth electrode part 240 of the ground electrode 222 comprises groundsensing parts 222B.

The ground electrode 222, such as the fourth electrode part 240 and thefifth electrode part 232, forms a first leakage electrode. The fourthelectrode 230 forms a second leakage electrode. The fifth electrode 232forms a third leakage electrode.

FIG. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings includingsix terminal openings. The plurality of terminal openings comprises aground terminal opening 242, a first terminal opening 244, a secondterminal opening 246, a third terminal opening 248, a fourth terminalopening 250, and a fifth terminal opening 252. The terminal openings242, 244, 246, 248, 250, 252 of the masking element 218 are configuredto overlap and/or be aligned with respective connection parts 222A,224A, 226A, 228A, 230A, 232A of the electrodes of the electrodeassembly.

The masking element 218 has a plurality of sensor point openings, whichmay be denoted as a second plurality of openings 253 of the maskingelement 218. The sensor point openings comprise primary sensor pointopenings shown within dotted line 254, each primary sensor point openingconfigured to overlap a part of a first leakage electrode, such as theground electrode 222, and/or a part of a second leakage electrode, suchas the fourth electrode 230. The primary sensor point openings 254comprise, in the illustrated exemplary masking element, five primaryfirst sensor point openings 254A each configured to overlap a part ofthe first leakage electrode, such as the ground electrode 222. Theprimary sensor point openings 254 comprise, in the illustrated exemplarymasking element, four primary second sensor point openings 254B eachconfigured to overlap a part of the second leakage electrode, such asthe fourth electrode 230. The sensor point openings comprise secondarysensor point openings shown within dotted line 256, each secondarysensor point opening configured to overlap a part of the second leakageelectrode, such as the fourth electrode 230, and/or a part of a thirdleakage electrode, such as the fifth electrode 232. The secondary sensorpoint openings 256 comprise, in the illustrated exemplary maskingelement, five secondary first sensor point openings 256A each configuredto overlap a part of the third leakage electrode, such as the fifthelectrode 232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, four secondary second sensorpoint openings 256B each configured to overlap a part of the secondleakage electrode, such as the fourth electrode 230. The sensor pointopenings comprise tertiary sensor point openings shown within dottedline 258, each tertiary sensor opening configured to overlap a part ofthe third leakage electrode, such as the fifth electrode 232, and/or apart of the first leakage electrode, such as the ground electrode 222.The tertiary sensor point openings 258 comprise, in the illustratedexemplary masking element, five tertiary first sensor point openings258A each configured to overlap a part of the third leakage electrode,such as the fifth electrode 232. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, four tertiarysecond sensor point openings 258B each configured to overlap a part ofthe first leakage electrode, such as the ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor point openings, which maybe denoted as the first plurality of openings 259 of the first adhesivelayer 200. The sensor point openings of the first adhesive layercomprise primary sensor point openings shown within dotted line 260,each primary sensor point opening configured to overlap a part of thefirst leakage electrode, such as the ground electrode 222, and/or a partof the second leakage electrode, such as the fourth electrode 230 of theelectrode assembly. The primary sensor point openings 260 comprise, inthe illustrated exemplary first adhesive layer, five primary firstsensor point openings 260A each configured to overlap a part of thefirst leakage electrode, such as the ground electrode 222. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, four primary second sensor point openings 260B eachconfigured to overlap a part of the second leakage electrode, such asthe fourth electrode 230. The sensor point openings of the firstadhesive layer comprise secondary sensor point openings shown withindotted line 262, each second sensor point opening configured to overlapa part of the second leakage electrode, such as the fourth electrode230, and/or a part of the third leakage electrode, such as the fifthelectrode 232 of the electrode assembly. The secondary sensor pointopenings 262 comprise, in the illustrated exemplary first adhesivelayer, five secondary first sensor point openings 262A each configuredto overlap a part of the third leakage electrode, such as the fifthelectrode 232. The secondary sensor point openings 262 comprise, in theillustrated exemplary first adhesive layer, four secondary second sensorpoint openings 262B each configured to overlap a part of the secondleakage electrode, such as the fourth electrode 230. The sensor pointopenings of the first adhesive layer comprise tertiary sensor pointopenings shown within dotted line 264, each tertiary sensor openingconfigured to overlap a part of the third leakage electrode, such as thefifth electrode 232, and/or a part of the first leakage electrode, suchas the ground electrode 222 of the electrode assembly. The tertiarysensor point openings 264 comprise, in the illustrated exemplary firstadhesive layer, five tertiary first sensor point openings 264A eachconfigured to overlap a part of the third leakage electrode, such as thefifth electrode 232. The tertiary sensor point openings 264 comprise, inthe illustrated exemplary first adhesive layer, four tertiary secondsensor point openings 264B each configured to overlap a part of thefirst leakage electrode, such as the ground electrode 222. FIG. 9 is aproximal view of the first adhesive layer of FIG. 8 .

FIG. 10 is a more detailed distal view of a part of the base plate 4and/or the sensor assembly part 700. The base plate 4 and/or the sensorassembly part 700 comprises a monitor interface. The monitor interfacecomprises the first connector 211. The first connector 211 comprisescoupling part 210 configured to releasably couple the monitor device tothe base plate and thus forming a releasable coupling. The firstconnector 211 of the monitor interface comprises a plurality ofterminals formed by respective terminal elements for forming respectiveelectrical connections with respective terminals of the monitor device.

The plurality of terminals of the first connector 211 of the monitorinterface comprises a ground terminal element 282 forming a groundterminal 282A, a first terminal element 284 forming a first terminal284, a second terminal element 286 forming a second terminal 286A, and athird terminal element 288 forming a third terminal 288A. The monitorinterface optionally comprises a fourth terminal element 290 forming afourth terminal 290A and/or a fifth terminal element 292 forming a fifthterminal 292A. The terminal elements 282, 284, 286, 288, 290, 292contact respective connection parts 222A, 224A, 226A, 228A, 230 a, 232Aof electrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate and/or the sensorassembly part, the number of terminals and the position of the terminalsin the coupling part may be adapted to the electrode configuration usedin the electrode assembly of the base plate and/or the sensor assemblypart.

In reference to FIG. 1 , FIG. 3 , FIG. 6 , and FIG. 10 , the monitorinterface 215 may include a plurality of terminals 212 and a couplingpart 210. The plurality of terminals 212 may be configured toelectrically couple the plurality of connection parts 221 of theplurality of electrodes 216 to the monitor device 6. The coupling part210 may be configured to releasably and structurally couple the baseplate 4 to the monitor device 6.

In reference to FIG. 3 and FIG. 10 , the coupling part 210 may bedistally attached or coupled to the top film 208, which may be distallycoupled to the first and/or second adhesive layers 200, 202 as describedpreviously. The coupling between the coupling part 210 and the top film208 may be achieved by means including but not limited to: heat-bonding,mechanical fastening, solvent-bonding, UV-bonding, adhesive bonding,and/or ultrasonic welding.

FIG. 11 is a proximal view of an exemplary base plate 4 showing theleakage of output 18. In embodiments, the base plate 4 and/or the sensorassembly part 700 may comprise one or more sensing zones 251 distributedangularly about the central region 400 of the base plate 4 and/or thesensor assembly part 700, as illustrated in FIG. 11 with three sensingzones 251. Alternatively or additionally, the one or more sensing zones251 may be distributed radially from the central region 400 of the baseplate 4 and/or the sensor assembly part 700, as illustrated in FIG. 15 ,and/or concentrically about the central region 400 of the base plate 4and/or the sensor assembly part, as illustrated in FIG. 16 .

The ostomy system 1 (FIG. 1 ) may be configured to detect the moisturecontent within the first adhesive layer 200 at each of the one or moresensing zones 251. In embodiments, the moisture content is detected bymeasuring a resistance at each of the one or more sensing zones 251across two of the plurality of electrodes 216 (see FIG. 6 ) in each ofthe one or more sensing zones 251. As will be described in greaterdetail, the ostomy system 1 may further be configured to detect theleakage of output, such as one or more indications of the leakage ofoutput, at each of the one or more sensing zones 251 based on theresistance measured.

In embodiments, the angular distribution of the one or more sensingzones 251 helps the ostomy system 1 detect the leakage of outputpropagating from the central region 400 of the base plate 4 and/or thesensor assembly part 700 towards the outer region 404 of the base plate4 and/or the sensor assembly part 700 in any direction within a baseplane defined by the proximal surface 200B of the first adhesive layer200. For example, as illustrated in FIG. 11 , a first sensing zone 251 aof the one or more sensing zones 251 may be disposed on a circle from 0to 120 degrees about the central opening 18 of the base plate 4 and/orthe sensor assembly part 700. Similarly, a second sensing zone 251 b ofthe one or more sensing zones 251 may be disposed on the circle from 120degrees to 240 degrees about the central opening 18 of the base plate 4and/or the sensor assembly part 700. Similarly, a third sensing zone 251c of the one or more sensing zones 251 may be disposed on the circlefrom 240 to 360 degrees about the central opening 18 of the base plate 4and/or the sensor assembly part 700.

Additionally or alternatively, the one or more sensing zones 251 may bedistributed radially (see FIG. 15 ) from the central region 400 of thebase plate 4 and/or the sensor assembly part 700 to help detect thepropagation of the leakage of output from the central region 400 towardsthe outer region 404 of the base plate 4 and/or the sensor assembly part700. Additionally or alternatively, the one or more sensing zones 251may be distributed concentrically about (see FIG. 16 ) the centralregion 400 of the base plate 4 and/or the sensor assembly part 700 tohelp detect the propagation of the leakage of output from the centralregion 400 towards the outer region 404 of the base plate 4 and/or thesensor assembly part 700 in any direction.

As will be described in greater detail, the known locations of the oneor more sensing zones 251 may further be used by the ostomy system 1,such as by the monitor device of the ostomy system, in determining apropagation direction and a propagation velocity of the leakage ofoutput.

As illustrated in FIG. 11 , the base plate 4 and/or the sensor assemblypart 700 may comprise a plurality of sensor points 270, wherein a partof one of the plurality of electrodes 216 is exposed (e.g. not coveredby the masking element 218 nor by the first adhesive layer 200) at eachof the plurality of sensor points. As will be described in more detail,the ostomy system 1 may be configured to detect the leakage of output,such as one or more indications of the leakage of output, using theplurality of sensor points. For example, when the leakage of output haspropagated far enough from the central region to reach a first sensorpoint 270 a and a second sensor point 270 b of the plurality of sensorpoints 270, as illustrated by FIG. 11 , the ostomy system 1 may beconfigured to determine the leakage of output has entered the firstsensing zone 251 a where the first and second sensor points 270 a, 270 bare located.

FIG. 12 is a proximal view of an exemplary base plate 4 and/or sensorassembly part 700 including a sensor point 270, such as a sensor pointof the plurality of sensor points as described, e.g. in relation to FIG.11 . The proximal surface 200B of the first adhesive layer 200 may beconfigured to be in contact with the skin of the user when the baseplate 4 and/or the sensor assembly part 700 is in use. As illustrated,the sensor point 270 is defined by an opening 259 of the first pluralityof openings of the first adhesive layer 200 aligned with an opening 253of the second plurality of openings of the masking element. In referenceto previous figures, each of the plurality of sensor points 270 isdefined by one of the first plurality of openings 259 (FIG. 8 ) of thefirst adhesive layer 200 aligning with one of the second plurality ofopenings 253 (FIG. 7 ) of the masking element 218 to expose a portion ofone of the plurality of electrodes 216. The aligned first and secondplurality of openings 253, 259 together define a plurality of conduits,such as sensor point openings, 272 (e.g. open channels from the skin tothe plurality of electrodes 216) configured for the leakage of output toenter and contact the exposed parts of the plurality of electrodes 216.Thereby, the skin is unlikely to contact the electrodes, whereas outputor other liquid may propagate through the sensor point openings 272 andprovide a sensor reading through a short-circuiting event.

In reference to FIG. 11 , the plurality of sensor points 270 maycomprise a plurality of sensor point groups 271 including primary sensorpoints 271 a, secondary sensor points 271 b, and tertiary sensor points271 c. Each of the primary sensor points 271 a includes an exposedportion of the ground electrode 222 of the plurality of electrodes 216(see FIG. 6 ). In reference to FIG. 6 and FIG. 11 , each of thesecondary sensor points 271 b includes an exposed portion of the fourthelectrode 230 of the plurality of electrodes 216. Each of the tertiarysensor points 271 c includes an exposed portion of a fifth electrode 232of the plurality of electrodes 216. As illustrated in FIG. 11 , theplurality of sensor points 270 are distributed alternatingly so that thenearest sensor point from a primary sensor point 271 a, such as any ofthe primary sensor points 271 a, is a secondary sensor point 271 b or atertiary sensor point 271 c. The nearest sensor point from a primarysensor point 271 a may not be another of the primary sensor points 271a. In such arrangement, any two of the plurality of sensor points 270neighboring each other would expose two of the plurality of electrodes216, which facilitates the detection of the leakage of output, such asone or more indications of the leakage of output.

Similar to the angular distribution of the one or more sensing zones251, as exemplified in FIG. 11 , the plurality of sensor points 270 maybe distributed angularly about the central region 400 of the base plate4 and/or the sensor assembly part 700 to help detect the leakage ofoutput propagating from the central region 400 of the base plate 4and/or the sensor assembly part 700 outwards towards the outer region404 of the base plate 4 and/or the sensor assembly part 700, e.g. in anydirection within the base plane. Additionally or alternatively, theplurality of sensor points 270 and/or sensing zones 251 may bedistributed radially (FIG. 15 ) from the central region 400 of the baseplate 4 and/or the sensor assembly part 700 to help detect thepropagation of the leakage of output from the central region 400 towardsthe outer region 404 of the base plate 4 and/or the sensor assembly part700. Additionally or alternatively, the plurality of sensor points 270and/or sensing zones 251 may be distributed concentrically (FIG. 16 )about the central region 400 of the base plate 4 and/or the sensorassembly part 700 to help detect the propagation of the leakage ofoutput from the central region 400 towards the outer region 404 of thebase plate 4 and/or the sensor assembly part 700, e.g. in any direction.

In embodiments, each of the one or more sensing zones 251 includes atleast sensing parts, e.g. 222B, 230B, 232B, (see FIG. 6 ) of two of theplurality of electrodes 216 such that each of the one or more sensingzones 251 may be generally defined, outlined, designated, and/orspecified by two of the plurality of electrodes 216. For example, theground and fourth of the plurality of electrodes 222, 230 may define thefirst sensing zone 251 a, the fourth electrode 230 and the fifthelectrode 232 of the plurality of electrodes 216 may define the secondsensing zone 251 b, and the ground electrode 222 and the fifth electrode232 of the plurality of electrodes 216 may define the third sensing zone251 c. The ground electrode 222 forms a first leakage electrode. Thefourth electrode 230 forms a second leakage electrode. The fifthelectrode 232 forms a third leakage electrode. In embodiments, at leastone of the plurality of electrodes 216 may be in more than one of theone or more sensing zones 251 (e.g. the ground electrode 222). Inaddition to the first, second, and third sensing zones 251 a, 251 b, and251 c, a sixth electrode, e.g. forming a fourth leakage electrode, ofthe plurality of electrodes may form a fourth, fifth, and sixth sensingzones with the ground, fourth, and/or fifth electrodes 222, 230, 232. Inembodiments, three or more of the plurality of electrodes 216 may be inone of the one or more sensing zone 251 such that two or moreresistances are measured across any two of the three or more of theplurality of electrodes 216, which in combination indicate the moisturecontent in the corresponding sensing zone 251.

In embodiments, each of the one or more sensing zones 251 includes atleast sensing parts of two of the plurality of sensor point groups 271,wherein each of the two of the plurality of sensor point groups 271exposes portions of one of the plurality of electrodes 216. For example,the first sensing zone 251 a may comprise some of the primary sensorpoints 271 a and some of the secondary sensor points 271 b. The secondsensing zone 251 b may comprise some of the secondary sensor points 271b and some of the tertiary sensor points 271 c. The third sensing zone251 c may comprise some of the primary sensor points 271 a and some ofthe tertiary sensor points 271 c.

As described previously, the ostomy system 1 may be configured to, bymeasuring resistances across the plurality of electrodes 216, detectleakage of output present in the base plane, such as one or moreindications of the leakage of output present in the base plane. Inembodiments, such detection of leakage of output and/or indication(s) ofleakage of output may be in the form of detection a short-circuit event.

FIG. 13 is a cross-sectional view of an exemplary base plate 4 and/orthe sensor assembly part 700 (as illustrated in FIG. 11 ) of the ostomysystem 1. In embodiments, the ostomy system 1 may be configured todetect a short-circuit event when the leakage of output connects onesensor point of one of the plurality of sensor groups 271 with onesensor point of another plurality of sensor groups 271. During suchshort-circuit event, the leakage of output 19 may contact one of theplurality of electrodes 216 by entering one of the plurality of sensorpoint openings 272 and contact another of the plurality of electrodes216 by entering another of the plurality of sensor point openings 272.In embodiments, the first adhesive layer 200 may be designed to have alower electrical conductivity than that of the output, such that theoutput would create a less resistive pathway between the two electrodescompared to a pathway through the first adhesive layer 200.

For example, the ostomy system 1 may be configured to detect ashort-circuit event in the first sensing zone 251 a when the leakage ofoutput 19 connects or bridges the ground electrode 222 and the fourthelectrode 230 in the first sensing zone—by way of entering one of theplurality of sensor point openings 272 exposing a portion of the groundelectrode 222 at one of the primary sensor points 271 a and enteringanother of the plurality of sensor point openings 272 exposing a portionof the fourth electrode 230 at one of the secondary sensor points 271 b.The output 19 connecting the ground and fourth electrodes 202, 220 wouldcreate a less resistive pathway than a pathway through the firstadhesive layer 200.

Similarly, the ostomy system 1 may detect a short-circuit event at anyof the one or more sensing zones indicative that the leakage of outputhas entered the corresponding sensing zone. This may be of importancedue to the presence of output between the first adhesive layer 200 ofthe base plate and/or the sensor assembly part and the skin of thepatient would indicate that the first adhesive layer 200 may no longeradhere (i.e. detached) to the skin of the patient. A detached firstadhesive layer 200 greatly increases the risk of leakage of outputexiting the containment of the ostomy appliance.

In embodiments, the first adhesive layer 200 is at least slightly airpermeable to help the leakage of output enter the plurality of sensorpoint openings 272 at the plurality of sensor points 270 with minimalresistive pressures created by the leakage of output compressing the airin the plurality of sensor point openings 272. In embodiments, theplurality of sensor point openings 272 is configured for the leakage ofoutput to easily enter such that the ostomy system 1 may detect theshort-circuit event and register the leakage signal less than 1 secondfrom the leakage of output entering the corresponding sensing zone.

FIG. 14 is a diagram illustrating exemplary resistance measurements.

A first resistance R₁ is measured in a first sensing zone. The firstresistance R₁ may be measured between a ground electrode and a fourthelectrode, e.g. a first leakage electrode and a second leakageelectrode, of the plurality of electrodes, wherein the ground and fourthelectrodes have exposed parts in the first sensing zone. As shown, thefirst resistance R₁ measured in the first sensing zone, before ashort-circuit event, substantially equals to a first primary resistancevalue R_(i1) The first primary resistance value R_(i1) has a relativelyhigh value and represents the relatively high electrical resistivity ofthe first adhesive layer and/or the masking layer between the twoelectrodes used by the monitor device of the ostomy system (FIG. 1 ) forresistance measurement at the first sensing zone. As illustrated in FIG.14 , the first resistance R₁ starts to drop from the first primaryresistance value R_(i1) to about a first secondary resistance valueR_(f1) when a short-circuit event occurred at time t₁. The firstsecondary resistance value R_(f1) has a relatively low value andrepresents the relatively low electrical resistivity of the output,which has connected the two electrodes used for the resistancemeasurement in the first sensing zone.

A second resistance R₂ is measured in a second sensing zone. The secondresistance R₂ may be measured between the fourth electrode and a fifthelectrode, e.g. the second leakage electrode and a third leakageelectrode, of the plurality of electrodes, wherein the fourth and fifthelectrode have exposed parts in the second sensing zone. As shown, thesecond resistance R₂ measured in the second sensing zone, before ashort-circuit event, substantially equals to a second primary resistancevalue R_(i2). The second primary resistance value R_(i2) has arelatively high value and represents the relatively high electricalresistivity of the first adhesive layer and/or the masking layer betweenthe two electrodes used by the monitor device of the ostomy system 1(FIG. 1 ) for resistance measurement of the second sensing zone. Asillustrated in FIG. 14 , the second resistance R₂ starts to drop fromthe second primary resistance value R_(i2) to about a second secondaryresistance value R_(f2) when a short-circuit event occurred at time t₂.The second secondary resistance value R_(f2) has a relatively low valueand represents the relatively low electrical resistivity of the output,which has connected the two electrodes used for the resistancemeasurement in the second sensing zone.

The monitor device 6 of the ostomy system 1 may be configured togenerate a leakage signal when a measured resistance, e.g. R₁ and/or R₂drops below a trigger resistance value, e.g. R_(t1) and/or R_(t2), e.g.at time t_(t1) and/or t_(t2), respectively, to indicate that ashort-circuit event has occurred in the corresponding sensing zone. Inembodiments, different threshold values may be employed for differentsensing zones, e.g. to reflect different electrode characteristics suchas electrode length and/or inter-electrode spacing.

In embodiments, the ostomy system is configured to detect leakage ofoutput propagating from the central opening 18 of the base plate and/orthe sensor assembly part towards the outer region 404 of the base plate4 and/or the sensor assembly part. Thus in addition to detectingshort-circuit events at the one or more sensing zones; the monitordevice 6 of the ostomy system 1 may be configured to generate leakagesignals. A leakage signal may comprise at least one of leakage location,leakage propagating direction, and leakage propagating velocity. Theleakage location may comprise the sensing zones where short-circuitevents have been detected. Additionally, the leakage location maycomprise a region between the sensing zones where short-circuit eventshave been detected.

In reference to FIG. 14 , the first derivative (slope) of the resistancedrop as a function of time, e.g. the rate of change of the resistance,may be correlated to the influx of moisture in the respective sensingzones. Additionally, the slope may provide information as to thequantity of moisture entering the corresponding sensing zone.Furthermore, the rate of change may be indicative of whether theunderlying cause of the detected increased moisture content. Forexample, a big rate of change may be indicative of output causing themoisture increase, while a smaller rate of change may be indicative ofsweat causing the moisture increase.

FIG. 15 and FIG. 16 each illustrates a base plate 4′, 4″ and/or a sensorassembly part with sensing zones arranged radially from (FIG. 15 ) andconcentrically about (FIG. 16 ) the central opening 18′, 18″, such asthe stomal opening, of the base plate 4′, 4″ and/or the sensor assemblypart and outwards towards the outer region 404′, 404″ of the base plate4′, 4″ and/or the sensor assembly part. When the sensing zones are insuch arrangement, the leakage propagating direction may comprise adirection from one of the one or more sensing zones 251′, 251″ thatfirst registered a short-circuit event, to another of the one or moresensing zones 251′, 251″ that next registered a short-circuit event. Theleakage propagating direction may be substantially parallel to the baseplate and/or the sensor assembly part and the base plane. The leakagepropagating velocity may comprise a velocity derived by dividing thedistance between the two sensing zones where short-circuit events havesequentially been detected, by a time-delay, e.g. At of FIG. 14 ,between the detection of short-circuit events at the two sensing zones(see FIG. 14 ).

In embodiments, the leakage propagating velocity derived may help theostomy system 1 in determining a remaining usage time (e.g. time tillreplacement) of the base plate 4. For example, from the known locationsof the sensing zones, the size of the first adhesive layer 200, adhesiveproperties (e.g. adhesive strength), and the derived leakage propagatingvelocity, the ostomy system 1 may be configured to determine theremaining time until the leakage of output spreads to substantialportions (or substantially near the outer region 404 of the base plate 4and/or the sensor assembly part) of the first adhesive layer 200. Theostomy system 1 may be configured to provide warning to the user suchthat the base plate 4 may be replaced before the leakage of output exitsthe containment of the ostomy appliance 2 due to greatly reducedadhesive strength between the base plate 4 and/or the sensor assemblypart and the skin of the user owing to the leakage of output. Such aprediction would help prevent unintended detachment of the base plate 4and/or the sensor assembly part and may further reduce the time ofcontact between the output and the skin of the user by indicating thatoutput is in contact with the skin and that the base plate 4 may be duefor a replacement or cleaning. The described warning may reduce skinproblems such as irritation or swelling that would result from the skinbeing in contact with output for extended period of time.

FIG. 15 also illustrates that the sensing zones may span a limited anglespace, such as an angle space of, e.g., 180 degrees. In the illustratedexample of FIG. 15 , the three sensing zones span the same angle space.However, it is noted that in other embodiments the plurality of sensingzones may span different angle spaces, such as illustrated in FIG. 11 .

FIG. 17 depicts an illustrative method 1800 for detecting a leakage ofoutput, such as one or more indications of the leakage of output,between a base plate and/or the sensor assembly part and the surface ofa subject, in accordance with embodiments. The method 1800 comprisesmeasuring 1802 one or more resistances via a plurality of electrodes 216of the base plate 4 and/or the sensor assembly part by a monitor device6 of the ostomy system 1. Each of the one or more resistances ismeasured by two of the plurality of electrodes 216 at one of the one ormore sensing zones 251.

The method 1800 may further comprise detecting 1804 the leakage ofoutput, such as one or more indications of the leakage of output, in oneor more sensing zones 251. Detecting 1804 may include comparing themeasured resistance to an initial/baseline resistance for each of theone or more sensing zones 251. When the leakage of output is present inone of the one or more sensing zones 216, one of the one or moreresistances measured 1802 at that sensing zone would decrease quickly.In embodiments, the detecting step 1804 comprises determining whethereach of the one or more resistances measured is smaller or equal to oneof the one or more threshold resistance values, wherein each of the oneor more threshold resistance values are the electrical resistancesmeasurable by the plurality of electrodes 216 in each of the one or moresensing zones 251 during a short-circuited event.

The method 1800 may further comprise generating 1806 a leakage signalwhen a leakage of output and/or one or more indications of the leakageof output has been detected in any of the one or more sensing zones 251.The leakage signal may comprise at least one of leakage location,leakage propagating direction, and leakage propagating velocity.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. does not imply any particular order, butare included to identify individual elements. Moreover, the use of theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not denote any order or importance, but rather theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used to distinguish one element from another. Notethat the words “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. are used here and elsewhere for labellingpurposes only and are not intended to denote any specific spatial ortemporal ordering. Furthermore, the labelling of a first element doesnot imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications and equivalents.

Embodiments of the present disclosure are set out in the followingitems:

-   -   1. An ostomy system configured to detect a leakage of output        between a base plate and/or a sensor assembly part of the ostomy        system and a surface of a subject, the ostomy system comprising:        -   a base plate and/or a sensor assembly part including:            -   a first adhesive layer having a distal surface, a                proximal surface, and a first plurality of openings, and            -   an electrode assembly disposed on the distal surface of                the first adhesive layer, the electrode assembly                including:                -   a plurality of electrodes, and                -   a masking element between the plurality of                    electrodes and the first adhesive layer, the masking                    element having a second plurality of openings                    aligned with the first plurality of openings of the                    first adhesive layer, each of the aligned first and                    second plurality of openings exposes a portion of                    one of the plurality of electrodes to define one of                    a plurality of sensor points; and        -   a monitor device electrically coupled to the plurality of            electrodes of the base plate and/or sensor assembly part,            the monitor device being configured to (i) measure one or            more resistances between the plurality of electrodes            and (ii) detect the leakage of output based on the measured            one or more resistances.    -   2. The ostomy system of item 1, wherein a first electrode and a        second electrode of the plurality of electrodes are configured        to short-circuit through the leakage of output when the leakage        of output connects the first and second electrodes at a first        sensor point and a second sensor point of the plurality of        sensor points, one of a plurality of conduits exposing a portion        of the first electrode at the first sensor point, and another of        the plurality of conduits exposing a portion of the second        electrode at the second sensor point.    -   3. The ostomy system of any of the preceding items, configured        to detect, using the one or more resistances measured by the        monitor device via the plurality of electrodes, the leakage of        output propagating from a central region of the base plate        and/or the sensor assembly part towards any direction in a base        plane defined by the proximal surface of the first adhesive        layer.    -   4. The ostomy system of any of the preceding items, wherein the        base plate and/or the sensor assembly part comprises one or more        sensing zones including a first sensing zone and a second        sensing zone, each of the one or more sensing zones includes at        least sensing parts of two of the plurality of electrodes.    -   5. The ostomy system of item 4, wherein at least some of the one        or more sensing zones being distributed at least one of        circularly about, radially from, and concentrically about a        central opening of the base plate and/or the sensor assembly        part.    -   6. The ostomy system of any of the preceding items, wherein the        first adhesive layer has a first electrical conductivity, the        masking element has a second electrical conductivity, and output        has a third electrical conductivity, wherein the second        electrical conductivity being lower than the first electrical        conductivity, and the third electrical conductivity being higher        than the first electrical conductivity.    -   7. The ostomy system of any of the preceding items, wherein the        masking element comprises at least one of polymeric and ceramic        materials.    -   8. The ostomy system of any of the preceding items, wherein the        plurality of electrodes comprises at least one of metallic,        ceramic, polymeric, and carbonaceous materials.    -   9. The ostomy system of any of the preceding items, wherein the        plurality of electrodes comprises one of silver and carbon.    -   10. The ostomy system of any of the preceding items, wherein the        base plate and/or the sensor assembly part is at least one of        bendable, flexible, twistable, and stretchable.    -   11. The ostomy system of any of the preceding items, wherein the        base plate and/or the sensor assembly part further comprises a        second adhesive layer coupled distally to the first adhesive        layer and the electrode assembly.    -   12. The ostomy system of item 11, wherein the second adhesive        layer is at least one of more adhesive to the surface of the        subject, more moisture permeable, less moisture-absorbent, and        lower in moisture capacity than the first adhesive layer.    -   13. The ostomy system of any of the preceding items, wherein the        base plate and/or the sensor assembly part further comprises a        release liner releasably attached to the proximal surface of the        first adhesive layer, the release liner having a plurality of        protrusions configured to extend into the first plurality of        openings of the first adhesive layer.    -   14. The ostomy system of any of the preceding items, wherein the        base plate and/or the sensor assembly part further comprises a        first intermediate element between the first adhesive layer and        a plurality of connection parts of the plurality of electrodes.    -   15. The ostomy system of item 14, wherein the first intermediate        element is less electrically conductive than the first adhesive        layer.    -   16. The ostomy system of any of the preceding items, wherein the        electrode assembly further comprises a support layer coupled to        the plurality of electrodes.    -   17. The ostomy system of any of the preceding items, wherein the        first adhesive layer comprises a hydrocolloid and a polymer        matrix.    -   18. The ostomy system of any of the preceding items, wherein the        monitor device is configured to generate a leakage signal when        the leakage of output is detected in at least one of the one or        more sensing zones.    -   19. A method of detecting a leakage of output between a base        plate and/or a sensor assembly part of an ostomy system and a        surface of a subject, the ostomy system including the base plate        and/or the sensor assembly part and a monitor device, the base        plate and/or the sensor assembly part comprising (i) a first        adhesive layer having a distal surface, a proximal surface, and        a first plurality of openings, and (ii) an electrode assembly        comprising a plurality of electrodes and a masking element        between the plurality of electrodes and the first adhesive        layer, the masking element having a second plurality of openings        aligned with the first plurality of openings of the first        adhesive layer, each of the aligned first and second plurality        of openings exposes a portion of one of the plurality of        electrodes to define one of a plurality of sensor points, the        monitor device electrically coupled to the plurality of        electrodes of the base plate and/or the sensor assembly part,        the method comprising:        -   measuring, via the plurality of electrodes, one or more            resistances, each of the one or more resistances measured            between two of the plurality of electrodes; and        -   detecting the leakage of output based on the measured one or            more resistances.    -   20. The method of item 19, wherein measuring, between the        plurality of electrodes, one or more resistances comprises:        -   measuring each of the one or more resistances in one or more            sensing zones including a first sensing zone and a second            sensing zone, wherein a first resistance of the one or more            resistances is measured for the first sensing zone and a            second resistance of the one or more resistances is measured            for the second sensing zone, the first resistance is            measured between two of the plurality of electrodes being            exposed by some of a plurality of conduits at some of the            plurality of sensor points in the first sensing zone, the            second resistance is measured between two of the plurality            of electrodes being exposed by some of the plurality of            conduits at some of the plurality of sensor points in the            second sensing zone.    -   21. The method of items 19 or 20, wherein detecting the leakage        of output comprises:        -   determining the leakage of output is present when one or            more of the one or more resistances measured is smaller or            equal to one of one or more threshold resistances.    -   22. The method of any of items 19-22, further comprising:        -   generating a leakage signal with the monitor device when the            leakage of output has been detected.    -   23. A sensor assembly part for an ostomy system, the sensor        assembly part including:        -   a first adhesive layer having a distal surface, a proximal            surface, and a first plurality of openings, the proximal            surface being configured for attachment of the sensor            assembly part to the skin surface of a user, and        -   an electrode assembly disposed on the distal surface of the            first adhesive layer, the electrode assembly including:            -   a plurality of electrodes, and            -   a masking element between the plurality of electrodes                and the first adhesive layer, the masking element having                a second plurality of openings aligned with the first                plurality of openings of the first adhesive layer to                form a plurality of sensor point openings, each of the                plurality of sensor point openings exposes a portion of                one of the plurality of electrodes to define one of a                plurality of sensor points.    -   24. The sensor assembly part of item 23, wherein a first leakage        electrode and a second leakage electrode of the plurality of        electrodes are configured to short-circuit through leakage of        output when the leakage of output connects the first and second        leakage electrodes at a first sensor point and a second sensor        point of the plurality of sensor points, one of the plurality of        sensor point openings exposing a portion of the first leakage        electrode at the first sensor point, and another of the        plurality of sensor point openings exposing a portion of the        second leakage electrode at the second sensor point.    -   25. The sensor assembly part of any of items 23-24 comprising        one or more sensing zones including a first sensing zone and a        second sensing zone, each of the one or more sensing zones        includes at least sensing parts of two of the plurality of        electrodes.    -   26. The sensor assembly part of item 25, wherein the plurality        of sensor point openings comprises a plurality of primary sensor        point openings in the first sensing zone and a plurality of        secondary sensor point openings in the second sensing zone, and        the plurality of primary sensor point openings comprises one or        more primary first sensor point openings exposing a portion of a        first leakage electrode of the plurality of electrodes, the        plurality of primary sensor point openings comprises one or more        primary second sensor point openings exposing a portion of a        second leakage electrode of the plurality of electrodes, the        plurality of secondary sensor point openings comprises one or        more secondary first sensor point openings exposing a portion of        a third leakage electrode of the plurality of electrodes, the        plurality of secondary sensor point openings comprises one or        more secondary second sensor point opening exposing a portion of        the second leakage electrode of the plurality of electrodes.    -   27. The sensor assembly part of any of items 25-26, wherein at        least some of the one or more sensing zones are distributed        angularly about and/or radially from a stomal opening of the        sensor assembly part.    -   28. The sensor assembly part of any of items 25-27, wherein the        first sensing zone is arranged in a first angle space from a        center point of a stomal opening of the sensor assembly part and        the second sensing zone is arranged in a second angle space from        the center point.    -   29. The sensor assembly part of any of items 25-28, wherein the        first sensing zone is arranged in a first radial space from a        center point of a stomal opening of the sensor assembly part and        the second sensing zone is arranged in a second radial space        from the center point.    -   30. The sensor assembly part of any of items 23-29, wherein the        first adhesive layer has a first electrical conductivity, the        masking element has a second electrical conductivity, and output        has a third electrical conductivity, wherein the second        electrical conductivity being lower than the first electrical        conductivity, and the third electrical conductivity being higher        than the first electrical conductivity.    -   31. The sensor assembly part of any of items 23-30, wherein the        masking element comprises at least one of polymeric and ceramic        materials.    -   32. The sensor assembly part of any of items 23-31, wherein the        plurality of electrodes comprises at least one of metallic,        ceramic, polymeric, and carbonaceous materials.    -   33. The sensor assembly part of any of items 23-32, wherein the        plurality of electrodes comprises one of silver and carbon.    -   34. The sensor assembly part of any of items 23-33 being at        least one of bendable, flexible, twistable, and stretchable.    -   35. The sensor assembly part of any of items 23-34 comprising a        second adhesive layer coupled distally to the first adhesive        layer and the electrode assembly.    -   36. The sensor assembly part of item 35, wherein the second        adhesive layer is at least one of more adhesive to the surface        of the subject, more moisture permeable, less        moisture-absorbent, and lower in moisture capacity than the        first adhesive layer.    -   37. The sensor assembly part of any of items 23-36 further        comprising a release liner releasably attached to the proximal        surface of the first adhesive layer, the release liner having a        plurality of protrusions configured to extend into the first        plurality of openings of the first adhesive layer.    -   38. The sensor assembly part of any of items 23-37 further        comprising a first intermediate element between the first        adhesive layer and a plurality of connection parts of the        plurality of electrodes.    -   39. The sensor assembly part of item 38, wherein the first        intermediate element is less electrically conductive than the        first adhesive layer.    -   40. The sensor assembly part of any of items 23-39, wherein the        electrode assembly further comprises a support layer coupled to        the plurality of electrodes.    -   41. The sensor assembly part of any of items 23-40, wherein the        first adhesive layer comprises a hydrocolloid and a polymer        matrix.    -   42. A base plate for an ostomy system, the base plate including:        -   a first adhesive layer having a distal surface, a proximal            surface, and a first plurality of openings, the proximal            surface being configured for attachment of the base plate to            the skin surface of a user, and        -   an electrode assembly disposed on the distal surface of the            first adhesive layer, the electrode assembly including:            -   a plurality of electrodes, and            -   a masking element between the plurality of electrodes                and the first adhesive layer, the masking element having                a second plurality of openings aligned with the first                plurality of openings of the first adhesive layer to                form a plurality of sensor point openings, each of the                plurality of sensor point openings exposes a portion of                one of the plurality of electrodes to define one of a                plurality of sensor points.    -   43. The base plate of item 42, wherein a first leakage electrode        and a leakage second electrode of the plurality of electrodes        are configured to short-circuit through leakage of output when        the leakage of output connects the first and second leakage        electrodes at a first sensor point and a second sensor point of        the plurality of sensor points, one of the plurality of sensor        point openings exposing a portion of the first leakage electrode        at the first sensor point, and another of the plurality of        sensor point openings exposing a portion of the second leakage        electrode at the second sensor point.    -   44. The base plate of any of items 42-43 comprising one or more        sensing zones including a first sensing zone and a second        sensing zone, each of the one or more sensing zones includes at        least sensing parts of two of the plurality of electrodes.    -   45. The base plate of item 44, wherein the plurality of sensor        point openings comprises a plurality of primary sensor point        openings in the first sensing zone and a plurality of secondary        sensor point openings in the second sensing zone, and the        plurality of primary sensor point openings comprises one or more        primary first sensor point openings exposing a portion of a        first leakage electrode of the plurality of electrodes, the        plurality of primary sensor point openings comprises one or more        primary second sensor point openings exposing a portion of a        second leakage electrode of the plurality of electrodes, the        plurality of secondary sensor point openings comprises one or        more secondary first sensor point openings exposing a portion of        a third leakage electrode of the plurality of electrodes, the        plurality of secondary sensor point openings comprises one or        more secondary second sensor point opening exposing a portion of        the second leakage electrode of the plurality of electrodes.    -   46. The base plate of any of items 44-45, wherein at least some        of the one or more sensing zones are distributed angularly about        and/or radially from a stomal opening of the base plate.    -   47. The base plate of any of items 44-46, wherein the first        sensing zone is arranged in a first angle space from a center        point of a stomal opening of the base plate and the second        sensing zone is arranged in a second angle space from the center        point.    -   48. The base plate of any of items 44-47, wherein the first        sensing zone is arranged in a first radial space from a center        point of a stomal opening of the base plate and the second        sensing zone is arranged in a second radial space from the        center point.    -   49. The base plate of any of items 42-48, wherein the first        adhesive layer has a first electrical conductivity, the masking        element has a second electrical conductivity, and output has a        third electrical conductivity, wherein the second electrical        conductivity being lower than the first electrical conductivity,        and the third electrical conductivity being higher than the        first electrical conductivity.    -   50. The base plate of any of items 42-49, wherein the masking        element comprises at least one of polymeric and ceramic        materials.    -   51. The base plate of any of items 42-50, wherein the plurality        of electrodes comprises at least one of metallic, ceramic,        polymeric, and carbonaceous materials.    -   52. The base plate of any of items 42-51, wherein the plurality        of electrodes comprises one of silver and carbon.    -   53. The base plate of any of items 42-52 being at least one of        bendable, flexible, twistable, and stretchable.    -   54. The base plate of any of items 42-53 comprising a second        adhesive layer coupled distally to the first adhesive layer and        the electrode assembly.    -   55. The base plate of item 54, wherein the second adhesive layer        is at least one of more adhesive to the surface of the subject,        more moisture permeable, less moisture-absorbent, and lower in        moisture capacity than the first adhesive layer.    -   56. The base plate of any of items 42-55 further comprising a        release liner releasably attached to the proximal surface of the        first adhesive layer, the release liner having a plurality of        protrusions configured to extend into the first plurality of        openings of the first adhesive layer.    -   57. The base plate of any of items 42-56 further comprising a        first intermediate element between the first adhesive layer and        a plurality of connection parts of the plurality of electrodes.    -   58. The base plate of item 57, wherein the first intermediate        element is less electrically conductive than the first adhesive        layer.    -   59. The base plate of any of items 42-58, wherein the electrode        assembly further comprises a support layer coupled to the        plurality of electrodes.    -   60. The base plate of any of items 42-59, wherein the first        adhesive layer comprises a hydrocolloid and a polymer matrix.

LIST OF REFERENCES

-   1 ostomy system-   2 ostomy appliance-   4 base plate-   4′ base plate-   4″ base plate-   6 monitor device-   8 accessory device-   10 server device-   12 network-   14 coupling member-   16 coupling ring-   18 stoma-receiving opening-   18′ stoma-receiving opening-   18″ stoma-receiving opening-   18 a central opening of first adhesive layer-   18 b central opening of second adhesive layer-   18 c central opening of electrode assembly-   19 output-   20 docking station-   22 first connector-   24 user interface-   100 monitor device housing-   101 processor-   102 first interface-   104 second interface-   106 memory-   108 ground terminal of monitor device-   110 first terminal of monitor device-   112 second terminal of monitor device-   114 third terminal of monitor device-   116 fourth terminal of monitor device-   118 fifth terminal of monitor device-   120 coupling part-   121 power unit-   122 antenna-   124 wireless transceiver-   126 loudspeaker-   128 haptic feedback element-   140 sensor unit-   200 first adhesive layer-   200A distal surface of first adhesive layer-   200B proximal surface of first adhesive layer-   202 second adhesive layer-   202A distal surface of second adhesive layer-   202B proximal surface of second adhesive layer-   204 electrode assembly-   204A distal surface of electrode assembly-   204B proximal surface of electrode assembly-   206 release liner-   206A distal surface of the release liner-   206B proximal surface of the release liner-   207 plurality of protrusions of the release liner-   208 top layer-   208A distal surface of the top layer-   208B proximal surface of the top layer-   209 coupling ring-   210 coupling part of first connector-   211 first connector-   212 terminals of first connector-   213 first intermediate element-   213A distal surface of first intermediate element-   213B proximal surface of first intermediate element-   214 support layer of electrode assembly-   214A distal surface of support layer-   214B proximal surface of support layer-   215 monitor interface-   216 electrodes of electrode assembly-   218 masking element-   218A distal surface of masking element-   218B proximal surface of masking element-   220 electrode configuration-   221 connection parts of the electrodes-   222 ground electrode-   222A ground connection part-   222B ground sensing part-   224 first electrode-   224A first connection part-   226 second electrode-   226A second connection part-   228 third electrode-   228A third connection part-   230 fourth electrode-   230A fourth connection part-   230B fourth sensing part-   232 fifth electrode-   232A fifth connection part-   232B fifth sensing part-   234 first electrode part of the ground electrode-   236 second electrode part of the ground electrode-   238 third electrode part of the ground electrode-   240 fourth electrode part of the ground electrode-   242 ground terminal opening-   244 first terminal opening-   246 second terminal opening-   248 third terminal opening-   250 fourth terminal opening-   251 one or more of sensing zones-   251 a first sensing zone-   251 b second sensing zone-   251 c third sensing zone-   251′ one or more of sensing zones-   251 a′ first sensing zone-   251 b′ second sensing zone-   251 c′ third sensing zone-   251″ one or more of sensing zones-   251 a″ first sensing zone-   251 b″ second sensing zone-   251 c″ third sensing zone-   252 fifth terminal opening-   253 second plurality of openings of the masking element-   254 primary sensor point openings of masking element-   254A primary first sensor point opening-   254B primary second sensor point opening-   256 secondary sensor point openings of masking element-   256A secondary first sensor point opening-   256B secondary second sensor point opening-   258 tertiary sensor point openings of masking element-   258A tertiary first sensor point opening-   258B tertiary second sensor point opening-   259 first plurality of openings of first adhesive layer-   260 primary sensor point openings of first adhesive layer-   260A primary first sensor point opening-   260B primary second sensor point opening-   262 secondary sensor point openings of first adhesive layer-   262A secondary first sensor point opening-   262B secondary second sensor point opening-   264 tertiary sensor point openings of first adhesive layer-   264A tertiary first sensor point opening-   264B tertiary second sensor point opening-   270 plurality of sensor points-   270 a first sensor point-   270 b second sensor point-   270 c third sensor point-   271 plurality of sensor point groups-   271 a primary sensor points-   271 b secondary sensor points-   271 c tertiary sensor points-   272 plurality of conduits-   282 ground terminal element-   282A ground terminal-   284 first terminal element-   284A first terminal-   286 second terminal element-   286A second terminal-   288 third terminal element-   288A third terminal-   290 fourth terminal element-   290A fourth terminal-   292 fifth terminal element-   292A fifth terminal-   400 central region of the ostomy base plate-   400′ central region of the ostomy base plate-   400″ central region of the ostomy base plate-   404 outer region of the ostomy base plate-   404′ outer region of the ostomy base plate-   404″ outer region of the ostomy base plate-   700 sensor assembly part-   R₁ resistance measured at the first sensing zone-   R₂ resistance measured at the second sensing zone-   R_(i1) first primary resistance value-   R_(i2) second primary resistance value-   R_(f1) first secondary resistance value-   R_(f2) second secondary resistance value-   R_(t1) first trigger resistance value-   R_(t2) second trigger resistance value-   t₁ time when short-circuit event occurs at the first sensing zone-   t₂ time when short-circuit event occurs at the second sensing zone-   t_(t1) time when resistance measured in the first sensing zone drops    below R_(t1)-   t_(t2) time when resistance measured in the second sensing zone    drops below R_(t2)-   Δt time-delay

The following is claimed:
 1. An ostomy system configured to detectleakage of output between a base plate of the ostomy system and a skinsurface of a subject, the ostomy system comprising: the base plateincluding: a first adhesive layer having a distal surface, a proximalsurface, and a first plurality of openings that extend from the proximalsurface to the distal surface, the proximal surface being configured forattachment of the base plate to the skin surface of a user, and anelectrode assembly disposed on the distal surface of the first adhesivelayer, the electrode assembly including: a plurality of electrodes, anda masking element between the plurality of electrodes and the firstadhesive layer, the masking element having a second plurality ofopenings aligned with the first plurality of openings of the firstadhesive layer to form a plurality of sensor point openings, each of theplurality of sensor point openings exposes a portion of one of theplurality of electrodes to define one of a plurality of sensor points;wherein the plurality of sensor point openings are configured to permitthe output to propagate through the sensor point openings and contactthe plurality of electrodes; and a monitor device electrically coupledto the plurality of electrodes of the base plate, the monitor devicebeing configured to (i) measure one or more resistances between theplurality of electrodes through the output and (ii) detect the leakageof output based on one or more resistances.
 2. The ostomy system ofclaim 1, wherein a first leakage electrode and a second leakageelectrode of the plurality of electrodes are configured to short-circuitthrough the leakage of output when the leakage of output connects thefirst and second leakage electrodes at a first sensor point and a secondsensor point of the plurality of sensor points, one of the plurality ofsensor point openings exposing a portion of the first leakage electrodeat the first sensor point, and another of the plurality of sensor pointopenings exposing a portion of the second leakage electrode at thesecond sensor point.
 3. The ostomy system of claim 1, configured todetect, using the one or more resistances measured by the monitor devicevia the plurality of electrodes, the leakage of output propagating froma central region of the base plate towards any direction in a base planedefined by the proximal surface of the first adhesive layer.
 4. Theostomy system of claim 1, wherein the base plate comprises one or moresensing zones including a first sensing zone and a second sensing zone,each of the one or more sensing zones includes at least sensing parts oftwo of the plurality of electrodes.
 5. The ostomy system of claim 4,wherein the plurality of sensor point openings comprises a plurality ofprimary sensor point openings in the first sensing zone and a pluralityof secondary sensor point openings in the second sensing zone, and theplurality of primary sensor point openings comprises one or more primaryfirst sensor point openings exposing a portion of a first leakageelectrode of the plurality of electrodes, the plurality of primarysensor point openings comprises one or more primary second sensor pointopenings exposing a portion of a second leakage electrode of theplurality of electrodes, the plurality of secondary sensor pointopenings comprises one or more secondary first sensor point openingsexposing a portion of a third leakage electrode of the plurality ofelectrodes, the plurality of secondary sensor point openings comprisesone or more secondary second sensor point openings exposing a portion ofthe second leakage electrode of the plurality of electrodes.
 6. Theostomy system of claim 4, wherein at least some of the one or moresensing zones are distributed angularly about and/or radially from astomal opening of the base plate.
 7. The ostomy system of claim 4,wherein the first sensing zone is arranged in a first angle space from acenter point of a stomal opening of the base plate and the secondsensing zone is arranged in a second angle space from the center point.8. The ostomy system of claim 4, wherein the first sensing zone isarranged in a first radial space from a center point of a stomal openingof the base plate and the second sensing zone is arranged in a secondradial space from the center point.
 9. The ostomy system of claim 1,wherein the first adhesive layer has a first electrical conductivity,the masking element has a second electrical conductivity, and theleakage of output has a third electrical conductivity, wherein thesecond electrical conductivity being lower than the first electricalconductivity, and the third electrical conductivity being higher thanthe first electrical conductivity.
 10. The ostomy system of claim 1,wherein the masking element comprises at least one of polymeric andceramic materials.
 11. The ostomy system of claim 1, wherein theplurality of electrodes comprises at least one of metallic, ceramic,polymeric, and carbonaceous materials.
 12. The ostomy system of claim 1,wherein the plurality of electrodes comprises one of silver and carbon.13. The ostomy system of claim 1, wherein the base plate is at least oneof bendable, flexible, twistable, and stretchable.
 14. The ostomy systemof claim 1, wherein the base plate further comprises a second adhesivelayer coupled distally to the first adhesive layer and the electrodeassembly.
 15. The ostomy system of claim 14, wherein the second adhesivelayer is at least one of more adhesive to the surface of the subject,more moisture permeable, less moisture-absorbent, and lower in moisturecapacity than the first adhesive layer.
 16. The ostomy system of claim1, wherein the base plate further comprises a release liner releasablyattached to the proximal surface of the first adhesive layer, therelease liner having a plurality of protrusions configured to extendinto the first plurality of openings of the first adhesive layer. 17.The ostomy system of claim 1, wherein the base plate further comprises afirst intermediate element between the first adhesive layer and aplurality of connection parts of the plurality of electrodes.
 18. Theostomy system of claim 17, wherein the first intermediate element isless electrically conductive than the first adhesive layer.
 19. Theostomy system of claim 1, wherein the electrode assembly furthercomprises a support layer coupled to the plurality of electrodes. 20.The ostomy system of claim 1, wherein the first adhesive layer comprisesa hydrocolloid and a polymer matrix.
 21. The ostomy system of claim 1,wherein the monitor device is configured to generate a leakage signalwhen the leakage of output is detected in one or more sensing zones. 22.A method of detecting a leakage of output between a base plate of anostomy system and a skin surface of a subject, the ostomy systemincluding the base plate and a monitor device, the base plate comprising(i) a first adhesive layer having a distal surface, a proximal surface,and a first plurality of openings that extend from the proximal surfaceto the distal surface, the proximal surface being configured forattachment of the base plate to the skin surface of a user, and (ii) anelectrode assembly comprising a plurality of electrodes and a maskingelement between the plurality of electrodes and the first adhesivelayer, the masking element having a second plurality of openings alignedwith the first plurality of openings of the first adhesive layer to forma plurality of sensor point openings, each of the plurality of sensorpoint openings exposes a portion of one of the plurality of electrodesto define one of a plurality of sensor points, wherein the plurality ofsensor point openings are configured to permit the output to propagatethrough the sensor point openings and contact the plurality ofelectrodes, the monitor device electrically coupled to the plurality ofelectrodes of the base plate, the method comprising: measuring, via theplurality of electrodes, one or more resistances, each of the one ormore resistances measured between two of the plurality of electrodesthrough the output; and detecting the leakage of output based on themeasured one or more resistances.
 23. The method of claim 22, whereinmeasuring, between the plurality of electrodes, one or more resistancescomprises: measuring each of the one or more resistances in one or moresensing zones including a first sensing zone and a second sensing zone,wherein a first resistance of the one or more resistances is measuredfor the first sensing zone and a second resistance of the one or moreresistances is measured for the second sensing zone, the firstresistance is measured between two of the plurality of electrodes beingexposed by some of the plurality of sensor point openings in the firstsensing zone, the second resistance is measured between two of theplurality of electrodes being exposed by some of the plurality of sensorpoint openings in the second sensing zone.
 24. The method of claim 22,wherein detecting the leakage of output comprises: determining that theleakage of output is present when at least one of the one or moreresistances measured is smaller or equal to one of one or more thresholdresistances.
 25. The method of claim 22, further comprising: generatinga leakage signal with the monitor device when the leakage of output hasbeen detected.
 26. A base plate for an ostomy system, the base platecomprising: a first adhesive layer having a distal surface, a proximalsurface, and a first plurality of openings that extend from the proximalsurface to the distal surface, the proximal surface being configured forattachment of the base plate to a skin surface of a user, and anelectrode assembly disposed on the distal surface of the first adhesivelayer, the electrode assembly including: a plurality of electrodes, anda masking element arranged between the plurality of electrodes and thefirst adhesive layer, the masking element having a second plurality ofopenings aligned with the first plurality of openings of the firstadhesive layer, each of the aligned first and second plurality ofopenings exposes a portion of one of the plurality of electrodes todefine one of a plurality of sensor points that are configured to permitoutput to propagate through the sensor point openings and contact theplurality of electrodes.